commit 56dd8a96281077271cbf565341c4bbbffad078f9 Author: williamwan Date: Thu Apr 16 13:15:17 2026 +0800 V 1.0 diff --git a/AI问答策略.md b/AI问答策略.md new file mode 100644 index 0000000..402c979 --- /dev/null +++ b/AI问答策略.md @@ -0,0 +1,142 @@ +# AI 问答策略 + +本文档定义：**用户在智能问答中提交自定义问题后**，系统（或对接的大模型）应遵循的总体流程，以及**按问题类型组织的回答思路**。实施时可作为 Prompt 设计、RAG 检索策略与后处理校验的共用规范。 + +--- + +## 一、文档用途 + +1. **自定义问题回答流程**：用户自由输入问题后，按第二节的流水线完成意图识别、数据与口径对齐、推理与输出，保证回答可追溯、口径一致。 +2. **分类型回答思路**：第三节按典型业务问题归类，给出「应从哪些角度组织答案」的检查清单；具体数值以当前权限内数仓 / 分析上下文为准。 + +--- + +## 二、自定义问题通用回答流程 + +建议固定为以下步骤（可部分自动化，但逻辑顺序不宜打乱）。 + +### 2.1 输入校验与安全 + +- 判空、过长截断提示、敏感操作拒绝（如导出未授权明细）。 +- 不臆造未在上下文或检索结果中出现的具体数字、医院名、批号等。 + +### 2.2 意图与领域分类 + +将用户问题归入一个或多个标签，例如： + +| 大类 | 说明 | 典型关键词或语义 | +|------|------|------------------| +| 不良事件（AE） | 条数、趋势、占比、省份/产品切片 | AE、不良事件、上报、SAE、发生月、报告条数 | +| 质量投诉 | 件数、结论、赔付、与 AE 关联 | 投诉、C3、调查结论、操作不当、关闭 | +| 营销 / 入院量 | 率、排名、与投诉联动 | 入院量、Qty、投诉率、每千件 | +| 合规审计 | 漏报、匹配规则、标记集合 | 漏报、合规、审计、匹配 | +| 元问题 | 数据范围、口径定义、Demo 说明 | 多少条数据、口径、时间范围 | + +无法归类时，先**澄清**（缺时间范围、统计维度、指标定义）再答，或给出**安全泛化**说明并建议可下钻维度。 + +### 2.3 指标与口径对齐 + +- 从**指标口径文档 / 本页约定**中解析：统计单元（如「报告条数」）、时间轴（如「发生日期」所在月 vs「审核日期」）、过滤条件（如是否含重复报告规则）。 +- 若用户口径与系统默认不一致，**显式说明**正在采用的定义，并提示如何按用户口径重新查询（若支持）。 + +### 2.4 数据与证据获取 + +- 拉取与问题匹配的**聚合结果**（趋势、对比、TopN、占比），必要时附**下钻维度**（产品、省份、医院、事业线、是否 SAE）。 +- 记录**证据摘要**（用于回答中的「依据当前数据集…」及后续审计追溯）。 + +### 2.5 组织答案结构 + +推荐顺序（可按问题类型裁剪）： + +1. **结论摘要**（一句话回应用户核心问法）。 +2. **关键数字**（绝对量、占比、同比/环比，与用户问法一致）。 +3. **对比与背景**（历史同期、相邻月份、同类产品线是否同步波动）。 +4. **可能解释**（分点列出假设因素，标注为「需结合业务验证」而非定论）。 +5. **局限与下一步**（样本量、缺失字段、建议图表或专题分析页）。 + +### 2.6 输出质量检查 + +- 数字与上下文一致；单位、时间范围写清。 +- 「因果」类表述避免绝对化：用「可能与…相关」「建议核查…」等措辞。 +- 附**来源**标签（如：聚合接口、预设模板、知识库片段），便于 Demo 与生产环境区分。 + +--- + +## 三、分类型问题：回答思路清单 + +### 3.1 AE 数量变化 / 「为何增加或减少」 + +用户关心的是**变化是否异常**以及**可能原因**，回答宜覆盖： + +1. **绝对值**：涉及月份（或区间）的报告条数各为多少；净增减多少条。 +2. **相对变化**：环比/同比**增长率或倍数**；避免仅用口语「翻倍」而不给基数。 +3. **历史可比性**：往年同月、近若干月的中位数或分位数；是否**首次出现**此类波动或**周期性重复**（如季节、集中上报批次）。 +4. **结构分解（产品因素）**：按事业线 / 产品 / 注册证 / 型号拆分，增量是否由**少数 SKU 或聚集事件**驱动。 +5. **结构分解（地域与机构）**：省份、医院是否有点状爆发；是否与新入院区域或新装机相关（若数据支持）。 +6. **报告与流程因素**：上报批次截止、监管填报窗口、重复报告剔除规则变更等**流程性解释**（需与合规口径一致）。 +7. **报告者 / 伤害与故障表现**：严重度（SAE 占比）、伤害表现或器械故障类别是否结构迁移（提示是否「报告质量或分类变化」而非单纯件数变化）。 +8. **收尾**：明确哪些结论可由当前数据直接支持，哪些需业务侧补充（临床反馈、批次调查、外部事件）。 + +### 3.2 AE 简单计数 / 排名类（如某月多少条、哪省最多） + +1. 直接给出**当前口径下**的数字或 Top 列表。 +2. 说明**时间维度**（发生月 / 审核月）与**统计范围**（全量 / 某产品线）。 +3. 若有并列第二、第三名，可一句带过以增强可比性。 + +### 3.3 两个月或多个月对比（「差异大吗」「哪个月更高」） + +1. 各月**绝对条数**并列。 +2. **差值与比率**（注意小基数时比率易失真，需提示）。 +3. **结构对比**：若条数接近，可对比 SAE 占比、产品构成是否不同。 +4. **解释边界**：样本随机波动 vs 可叙述的业务假设，分条列出并标注置信程度。 + +### 3.4 合规与漏报 / 匹配审计类 + +1. 说明**基准集合**定义（例如：投诉标记为不良事件的记录数）。 +2. 给出**匹配规则摘要**（如医院 + 产品 + 型号，时间窗 ≤30 天等，以实际规则为准）。 +3. 输出**疑似漏报条数与漏报率**，并说明「疑似」含义及人工复核必要性。 + +### 3.5 质量投诉：调查结论、操作不当、医院排名等 + +1. 明确统计的是**投诉条数**还是**已关闭子集**等。 +2. 给出**分布或 TopN**；若问「最多」，写清维度（如调查结论 = 操作不当）。 +3. 与 AE 或营销页**交叉引用**时，说明是否为同一数据源、时间是否对齐。 + +### 3.6 营销：投诉率（如每千件入院量）、省级对比 + +1. 写清**分子**（投诉条数如何映射到省）、**分母**（入院 Qty 汇总口径）。 +2. 给出**率值与排名**；注意极低分母导致的极值，必要时提示稳健性。 +3. 区分「投诉多」与「率高」：入院量大的省份可能件数多但率不高。 + +### 3.7 占比类（如 SAE 占 AE、调查结论占比） + +1. 定义**分母**（全部 AE、全部投诉等）。 +2. 给出**整体或按月的比例**；若给平均值，说明时间范围。 +3. 指向可视化（曲线/饼图）以便用户复核。 + +### 3.8 数据范围与元问题（多少条记录、Demo 说明） + +1. 当前加载或权限范围内的**表名 + 记录数 + 时间跨度**。 +2. 说明与正式环境的差异（mock、缓存、权限）。 + +### 3.9 无法命中或超出数据能力 + +1. 礼貌说明**未命中**或可答部分。 +2. 列出**建议改写**或**可支持的关键词 / 维度**（与产品示例问题对齐）。 +3. 生产环境：说明可对接**数仓 / 文档检索 / 人工工单**等扩展路径。 + +--- + +## 四、与实现的衔接建议 + +- **前端 / Demo**：可将用户问题、当前 `AnalysisContext` 摘要、本策略第三节匹配到的小节标题，一并作为 System 或 Tool 提示，约束模型输出结构。 +- **知识库**：将《数据与表结构》、各分析页指标编号（如 MKT-RG-201）与本文档第二节、第三节联合检索，减少口径漂移。 +- **评测**：对每类问题准备标准问法与必含要点（如 3.1 须含绝对值 + 百分比 + 至少两类因素分解），用于回归测试。 + +--- + +## 五、修订记录 + +| 版本 | 日期 | 说明 | +|------|------|------| +| 0.1 | 2026-04-16 | 初稿：通用流程 + 分类型思路（含 AE 增减分析维度） | diff --git a/analytics-demo-web/.gitignore b/analytics-demo-web/.gitignore new file mode 100644 index 0000000..a547bf3 --- /dev/null +++ b/analytics-demo-web/.gitignore @@ -0,0 +1,24 @@ +# Logs +logs +*.log +npm-debug.log* +yarn-debug.log* +yarn-error.log* +pnpm-debug.log* +lerna-debug.log* + +node_modules +dist +dist-ssr +*.local + +# Editor directories and files +.vscode/* +!.vscode/extensions.json +.idea +.DS_Store +*.suo +*.ntvs* +*.njsproj +*.sln +*.sw? diff --git a/analytics-demo-web/.vscode/extensions.json b/analytics-demo-web/.vscode/extensions.json new file mode 100644 index 0000000..a7cea0b --- /dev/null +++ b/analytics-demo-web/.vscode/extensions.json @@ -0,0 +1,3 @@ +{ + "recommendations": ["Vue.volar"] +} diff --git a/analytics-demo-web/README.md b/analytics-demo-web/README.md new file mode 100644 index 0000000..33895ab --- /dev/null +++ b/analytics-demo-web/README.md @@ -0,0 +1,5 @@ +# Vue 3 + TypeScript + Vite + +This template should help get you started developing with Vue 3 and TypeScript in Vite. 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false + }, + { + "reportCode": "SIM-2024-000065", + "occurrenceDate": "2025-10-29", + "registrationDate": "2025-11-08", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准2015385972", + "model": "PF-7.0", + "batchNo": "E7525187", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2025-11-14", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000066", + "occurrenceDate": "2025-02-09", + "registrationDate": "2025-02-16", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注准2015596818", + "model": "Dafilon 5-0", + "batchNo": "E4541844", + "injuryExpression": "异物感", + "deviceFailure": "线结切割组织", + "reviewDate": "2025-02-19", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + 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"saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000077", + "occurrenceDate": "2025-11-22", + "registrationDate": "2025-11-24", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2016973120", + "model": "IS-5.0", + "batchNo": "K5320096", + "injuryExpression": "渗漏致皮肤红斑", + "deviceFailure": "穿刺器与药瓶胶塞密封不严", + "reviewDate": "2025-11-28", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000078", + "occurrenceDate": "2023-12-23", + "registrationDate": "2024-01-04", + "unitName": "郑州大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注进2017476402", + "model": "AV-SET-P", + "batchNo": "F7447229", + "injuryExpression": "出血", + "deviceFailure": "泵管段磨损起皱", + "reviewDate": "2024-01-12", + "province": "河南省", + "saeDeath": 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+ "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000081", + "occurrenceDate": "2025-08-17", + "registrationDate": "2025-08-22", + "unitName": "山东大学齐鲁医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注准2017398947", + "model": "ACID-8L", + "batchNo": "G5114580", + "injuryExpression": "恶心", + "deviceFailure": "浓缩液桶盖密封条变形渗漏", + "reviewDate": "2025-08-29", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000082", + "occurrenceDate": "2025-03-20", + "registrationDate": "2025-03-23", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进2015387557", + "model": "Diacap Pro 1.3", + "batchNo": "K1723821", + "injuryExpression": "出血", + "deviceFailure": "动脉端管路接头渗液", + "reviewDate": "2025-03-28", + 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"reviewDate": "2024-10-04", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000087", + "occurrenceDate": "2024-05-26", + "registrationDate": "2024-05-29", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准207549201", + "model": "IS-5.0", + "batchNo": "D8412755", + "injuryExpression": "寒战", + "deviceFailure": "输液管路可见异物附着", + "reviewDate": "2024-06-03", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000088", + "occurrenceDate": "2024-07-15", + "registrationDate": "2024-07-24", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准208499510", + "model": "IS-5.0", + "batchNo": "F1421850", + "injuryExpression": "瘙痒", + "deviceFailure": "精密过滤器外壳裂纹", + "reviewDate": "2024-07-29", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000089", + "occurrenceDate": "2025-12-17", + "registrationDate": "2025-12-27", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进207318216", + "model": "Diacap 1.4", + "batchNo": "C9204134", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2026-01-02", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000090", + "occurrenceDate": "2026-02-08", + "registrationDate": "2026-02-13", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2016311455", + "model": "EN-SET-2.0", + "batchNo": "H5255983", + "injuryExpression": "腹胀", + "deviceFailure": 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"deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2024-04-02", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000093", + "occurrenceDate": "2025-07-11", + "registrationDate": "2025-07-20", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2016600201", + "model": "Introcan 18G", + "batchNo": "E6026960", + "injuryExpression": "出血", + "deviceFailure": "针尖保护装置回弹不畅", + "reviewDate": "2025-07-25", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000094", + "occurrenceDate": "2024-12-05", + "registrationDate": "2024-12-06", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2015176475", + "model": "4251624", + "batchNo": "B7662792", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2024-12-09", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000095", + "occurrenceDate": "2024-01-04", + "registrationDate": "2024-01-15", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准205339536", + "model": "SAFE-ABG", + "batchNo": "F8821981", + "injuryExpression": "血肿", + "deviceFailure": "针头保护套脱落困难", + "reviewDate": "2024-01-22", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000096", + "occurrenceDate": "2025-03-08", + "registrationDate": "2025-03-20", + "unitName": "郑州大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2018547386", + "model": "Monosyn 4-0", + "batchNo": "E7980877", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-03-28", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000097", + "occurrenceDate": "2024-08-20", + "registrationDate": "2024-09-01", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2015244827", + "model": "IS-7.0", + "batchNo": "F5845083", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2024-09-09", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000098", + "occurrenceDate": "2024-01-01", + "registrationDate": "2024-01-04", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进206158882", + "model": "PF-7.0", + "batchNo": "K9617138", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2024-01-09", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000099", + "occurrenceDate": "2025-08-22", + "registrationDate": "2025-08-31", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准208694219", + "model": "4251624", + "batchNo": "H9095110", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2025-09-05", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000100", + "occurrenceDate": "2024-11-28", + "registrationDate": "2024-11-30", + "unitName": "上海市第一人民医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注进209146179", + "model": "AV-SET-A", + "batchNo": "C3034931", + "injuryExpression": "出血", + "deviceFailure": "泵管段磨损起皱", + "reviewDate": "2024-12-04", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000101", + "occurrenceDate": "2024-08-12", + "registrationDate": "2024-08-22", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进2019191936", + "model": "Monosyn 4-0", + "batchNo": "E9851402", + "injuryExpression": "感染征象", + "deviceFailure": "缝线张力过早丧失", + "reviewDate": "2024-08-28", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000102", + "occurrenceDate": "2024-01-04", + "registrationDate": "2024-01-12", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2019269420", + "model": "4251625", + "batchNo": "J4121174", + "injuryExpression": "瘙痒", + "deviceFailure": "延长管打折致滴速下降", + "reviewDate": "2024-01-16", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000103", + "occurrenceDate": "2025-02-10", + "registrationDate": "2025-02-14", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进206406465", + "model": "PF-5.0", + "batchNo": "D5895529", + "injuryExpression": "低血压", + "deviceFailure": "过滤膜侧压力升高致滴速骤降", + "reviewDate": "2025-02-20", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000104", + "occurrenceDate": "2024-10-14", + "registrationDate": "2024-10-21", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准206971792", + "model": "PF-7.0", + "batchNo": "G6324593", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2024-10-24", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000105", + "occurrenceDate": "2025-09-23", + "registrationDate": "2025-10-03", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进205210751", + "model": "IS-5.0", + "batchNo": "E3703129", + "injuryExpression": "寒战", + "deviceFailure": "输液管路可见异物附着", + "reviewDate": "2025-10-09", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000106", + "occurrenceDate": "2025-01-16", + "registrationDate": "2025-01-17", + "unitName": "山东大学齐鲁医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准207726632", + "model": "ABG-3ml", + "batchNo": "B4342377", + "injuryExpression": "疼痛", + "deviceFailure": "采血后桡动脉痉挛", + "reviewDate": "2025-01-20", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000107", + "occurrenceDate": "2024-10-05", + "registrationDate": "2024-10-07", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2018841979", + "model": "4053000", + "batchNo": "A2701686", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2024-10-11", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000108", + "occurrenceDate": "2024-09-29", + "registrationDate": "2024-10-04", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2018160277", + "model": "Introcan Safety 20G", + "batchNo": "B2725649", + "injuryExpression": "血肿", + "deviceFailure": "回血观察窗模糊影响血流判断", + "reviewDate": "2024-10-11", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000109", + "occurrenceDate": "2024-07-27", + "registrationDate": "2024-08-07", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注进2019296456", + "model": "EN-SET-1.2", + "batchNo": "G3366600", + "injuryExpression": "腹胀", + "deviceFailure": "营养袋接口与泵管连接处渗漏", + "reviewDate": "2024-08-14", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000110", + "occurrenceDate": "2024-08-08", + "registrationDate": "2024-08-13", + "unitName": 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false + }, + { + "reportCode": "SIM-2024-000126", + "occurrenceDate": "2024-06-14", + "registrationDate": "2024-06-26", + "unitName": "天津市肿瘤医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进2018390997", + "model": "ACID-8L", + "batchNo": "H9408374", + "injuryExpression": "呕吐", + "deviceFailure": "电导度监测短暂漂移", + "reviewDate": "2024-07-04", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000127", + "occurrenceDate": "2025-04-15", + "registrationDate": "2025-04-18", + "unitName": "天津市肿瘤医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准206271486", + "model": "ABG-3ml", + "batchNo": "G5772441", + "injuryExpression": "疼痛", + "deviceFailure": "采血后桡动脉痉挛", + "reviewDate": "2025-04-23", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000128", + "occurrenceDate": "2025-07-26", + "registrationDate": "2025-08-06", + "unitName": "山东大学齐鲁医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注准206674632", + "model": "OP-FILM-45", + "batchNo": "C3156967", + "injuryExpression": "皮肤红斑", + "deviceFailure": "粘性不足边缘翘起", + "reviewDate": "2025-08-13", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000129", + "occurrenceDate": "2024-10-26", + "registrationDate": "2024-10-28", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进207810937", + "model": "IS-5.0", + "batchNo": "E3993714", + "injuryExpression": "瘙痒", + "deviceFailure": "精密过滤器外壳裂纹", + "reviewDate": "2024-11-01", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000130", + "occurrenceDate": "2024-05-23", + "registrationDate": "2024-06-03", + "unitName": "中南大学湘雅医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进207771429", + "model": "IS-5.0", + "batchNo": "E6449474", + "injuryExpression": "渗漏致皮肤红斑", + "deviceFailure": "穿刺器与药瓶胶塞密封不严", + "reviewDate": "2024-06-10", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000131", + "occurrenceDate": "2024-01-12", + "registrationDate": "2024-01-23", + "unitName": "上海市第一人民医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注进2018953418", + "model": "AV-SET-P", + "batchNo": "C9155978", + "injuryExpression": "失血相关血红蛋白下降", + "deviceFailure": "动脉壶液面持续下降", + "reviewDate": "2024-01-30", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + 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"saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000134", + "occurrenceDate": "2025-10-18", + "registrationDate": "2025-10-26", + "unitName": "四川大学华西医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准205790869", + "model": "EX-50cm", + "batchNo": "F4811787", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2025-10-30", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000135", + "occurrenceDate": "2024-11-21", + "registrationDate": "2024-11-24", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进207455775", + "model": "Monosyn 4-0", + "batchNo": "H3231958", + "injuryExpression": "感染征象", + "deviceFailure": "缝线张力过早丧失", + "reviewDate": "2024-11-29", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000136", + "occurrenceDate": "2023-12-18", + "registrationDate": "2023-12-19", + "unitName": "中南大学湘雅医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注准2018539855", + "model": "BIC-35", + "batchNo": "H9151154", + "injuryExpression": "呕吐", + "deviceFailure": "电导度监测短暂漂移", + "reviewDate": "2023-12-22", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000137", + "occurrenceDate": "2025-03-10", + "registrationDate": "2025-03-19", + "unitName": "四川大学华西医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准205710516", + "model": "Introcan Safety 20G", + "batchNo": "J7062463", + "injuryExpression": "静脉炎", + "deviceFailure": "导管腔内回血阻力增高", + "reviewDate": "2025-03-24", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000138", + "occurrenceDate": "2023-12-15", + "registrationDate": "2023-12-17", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2019969269", + "model": "IS-5.0", + "batchNo": "A7511763", + "injuryExpression": "恶心", + "deviceFailure": "滴速过快相关不适", + "reviewDate": "2023-12-21", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000139", + "occurrenceDate": "2024-07-04", + "registrationDate": "2024-07-13", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准205778832", + "model": "PF-5.0", + "batchNo": "B7537298", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2024-07-18", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000140", + "occurrenceDate": "2024-09-30", + "registrationDate": "2024-10-06", + "unitName": "山东大学齐鲁医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进2015881139", + "model": "Diacap Pro 1.3", + "batchNo": "J8738522", + "injuryExpression": "胸痛", + "deviceFailure": "静脉压升高报警", + "reviewDate": "2024-10-14", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000141", + "occurrenceDate": "2024-08-28", + "registrationDate": "2024-08-31", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进207702269", + "model": "PF-7.0", + "batchNo": "H2891531", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2024-09-05", + "province": 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"2025-03-25", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000144", + "occurrenceDate": "2025-07-01", + "registrationDate": "2025-07-05", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准2015340642", + "model": "PF-7.0", + "batchNo": "E3085023", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2025-07-11", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000145", + "occurrenceDate": "2024-02-20", + "registrationDate": "2024-03-03", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注准206816361", + "model": "20ml Luer", + "batchNo": "B4174451", + "injuryExpression": "局部肿胀", + "deviceFailure": "针头与针座连接处渗漏", + "reviewDate": "2024-03-11", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000146", + "occurrenceDate": "2024-06-14", + "registrationDate": "2024-06-16", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2018803823", + "model": "Monosyn 4-0", + "batchNo": "F6278861", + "injuryExpression": "出血", + "deviceFailure": "线体断裂残留", + "reviewDate": "2024-06-20", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000147", + "occurrenceDate": "2024-12-26", + "registrationDate": "2024-12-28", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2015140359", + "model": "EN-SET-2.0", + "batchNo": "E5174528", + "injuryExpression": "腹胀", + "deviceFailure": 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"deviceFailure": "透析器外壳细微裂纹", + "reviewDate": "2024-09-25", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000150", + "occurrenceDate": "2025-06-08", + "registrationDate": "2025-06-16", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进207754965", + "model": "IS-7.0", + "batchNo": "K5317805", + "injuryExpression": "瘙痒", + "deviceFailure": "精密过滤器外壳裂纹", + "reviewDate": "2025-06-20", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000151", + "occurrenceDate": "2025-01-21", + "registrationDate": "2025-01-25", + "unitName": "南京鼓楼医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注准205629382", + "model": "OP-FILM-45", + "batchNo": "G8000388", + "injuryExpression": "瘙痒", + "deviceFailure": "敷料下汗液积聚刺激", + "reviewDate": "2025-01-31", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000152", + "occurrenceDate": "2025-12-14", + "registrationDate": "2025-12-17", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准206582613", + "model": "Monosyn 4-0", + "batchNo": "K9230345", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-12-22", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000153", + "occurrenceDate": "2024-06-05", + "registrationDate": "2024-06-11", + "unitName": "天津市肿瘤医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2015519946", + "model": "Monosyn 4-0", + "batchNo": "K3756880", + "injuryExpression": "切口裂开", + "deviceFailure": "缝线结滑脱", + "reviewDate": "2024-06-19", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000154", + "occurrenceDate": "2026-01-17", + "registrationDate": "2026-01-24", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注准209918235", + "model": "AV-SET-A", + "batchNo": "A6007214", + "injuryExpression": "出血", + "deviceFailure": "泵管段磨损起皱", + "reviewDate": "2026-01-27", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000155", + "occurrenceDate": "2025-10-18", + "registrationDate": "2025-10-23", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准205938887", + "model": "EX-100cm", + "batchNo": "A6404716", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2025-10-30", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000156", + "occurrenceDate": "2025-07-20", + "registrationDate": "2025-07-24", + "unitName": "郑州大学第一附属医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注准207265356", + "model": "Premilene 3-0", + "batchNo": "J1353836", + "injuryExpression": "红斑", + "deviceFailure": "缝线表面粗糙刺激", + "reviewDate": "2025-07-30", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000157", + "occurrenceDate": "2025-09-15", + "registrationDate": "2025-09-26", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进2016140351", + "model": "Novosyn 3-0", + "batchNo": "D2168026", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-10-03", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000158", + "occurrenceDate": "2025-06-18", + "registrationDate": "2025-06-28", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注进208636613", + "model": "OP-FILM-60", + "batchNo": "C3593614", + "injuryExpression": "疼痛", + "deviceFailure": "去除敷料时皮肤撕脱", + "reviewDate": "2025-07-04", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000159", + "occurrenceDate": "2025-08-18", + "registrationDate": "2025-08-24", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进206983475", + "model": "IS-7.0", + "batchNo": "C3291368", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2025-09-01", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000160", + "occurrenceDate": "2026-03-26", + "registrationDate": "2026-03-28", + "unitName": "四川大学华西医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进208281475", + "model": "HD-180", + "batchNo": "H9572290", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2026-04-01", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000161", + "occurrenceDate": "2025-02-26", + "registrationDate": "2025-03-08", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2019873316", + "model": "4251625", + "batchNo": "E2514857", + "injuryExpression": "出血", + "deviceFailure": "针尖保护装置回弹不畅", + "reviewDate": "2025-03-14", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000162", + "occurrenceDate": "2025-07-25", + "registrationDate": "2025-07-27", + "unitName": "上海市第一人民医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准207776836", + "model": "Monosyn 4-0", + "batchNo": "D1898032", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-07-31", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000163", + "occurrenceDate": "2024-11-07", + "registrationDate": "2024-11-10", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准207457787", + "model": "PF-7.0", + "batchNo": "B4775882", + "injuryExpression": "胸闷", + "deviceFailure": "侧孔进气不畅", + "reviewDate": "2024-11-15", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000164", + "occurrenceDate": "2025-06-02", + "registrationDate": "2025-06-03", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2017745696", + "model": "Novosyn 3-0", + "batchNo": "B4969051", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-06-06", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000165", + "occurrenceDate": "2024-05-02", + "registrationDate": "2024-05-13", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注进208173373", + "model": "EX-100cm", + "batchNo": "F2430774", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2024-05-20", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000166", + "occurrenceDate": "2025-03-30", + "registrationDate": "2025-04-03", + "unitName": "山东大学齐鲁医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准205955338", + "model": "Diacap Pro 1.3", + "batchNo": "H3994527", + "injuryExpression": "肌肉痉挛", + "deviceFailure": "透析器外壳细微裂纹", + "reviewDate": "2025-04-09", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000167", + "occurrenceDate": "2024-08-30", + "registrationDate": "2024-09-04", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注进208793667", + "model": "EX-50cm", + "batchNo": "E7290465", + "injuryExpression": "局部肿胀", + "deviceFailure": "接口渗液", + "reviewDate": "2024-09-11", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000168", + "occurrenceDate": "2024-05-19", + "registrationDate": "2024-05-24", + "unitName": "郑州大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注准208282343", + "model": "AV-SET-P", + "batchNo": "A8683642", + "injuryExpression": "出血", + "deviceFailure": "泵管段磨损起皱", + "reviewDate": "2024-05-31", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000169", + "occurrenceDate": "2023-12-12", + "registrationDate": "2023-12-19", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2017449432", + "model": "EN-SET-2.0", + "batchNo": "J8249874", + "injuryExpression": "腹泻", + "deviceFailure": "营养液温度偏低相关不适", + "reviewDate": "2023-12-22", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000170", + "occurrenceDate": "2025-11-03", + "registrationDate": "2025-11-14", + "unitName": "山东大学齐鲁医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准205574081", + "model": "Novosyn 3-0", + "batchNo": "K1037465", + "injuryExpression": "切口裂开", + "deviceFailure": "缝线结滑脱", + "reviewDate": "2025-11-21", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000171", + "occurrenceDate": "2025-12-05", + "registrationDate": "2025-12-09", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准207363561", + "model": "Novosyn 3-0", + "batchNo": "D4512594", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-12-15", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000172", + "occurrenceDate": "2025-01-11", + "registrationDate": "2025-01-13", + "unitName": "中南大学湘雅医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注准2015241648", + "model": "Premilene 3-0", + "batchNo": "D4512594", + "injuryExpression": "红斑", + "deviceFailure": "缝线表面粗糙刺激", + "reviewDate": "2025-01-17", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000173", + "occurrenceDate": "2024-01-26", + "registrationDate": "2024-01-31", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准205307453", + "model": "Introcan Safety 20G", + "batchNo": "F7321089", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2024-02-07", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000174", + "occurrenceDate": "2025-12-02", + "registrationDate": "2025-12-12", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2016673673", + "model": "4251624", + "batchNo": "H8006848", + "injuryExpression": "局部感染征象", + "deviceFailure": "三通接头裂纹", + "reviewDate": "2025-12-18", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000175", + "occurrenceDate": "2024-04-05", + "registrationDate": "2024-04-11", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进208569574", + "model": "IS-5.0", + "batchNo": "D2329650", + "injuryExpression": "输液部位疼痛", + "deviceFailure": "滴斗液面波动异常", + "reviewDate": "2024-04-19", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000176", + "occurrenceDate": "2024-06-28", + "registrationDate": "2024-07-04", + "unitName": "广东省人民医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注准2019908109", + "model": "Premilene 3-0", + "batchNo": "D6103402", + "injuryExpression": "水肿", + "deviceFailure": "缝针与线体连接处松动", + "reviewDate": "2024-07-12", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000177", + "occurrenceDate": "2024-08-15", + "registrationDate": "2024-08-23", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进209512327", + "model": "Novosyn 3-0", + "batchNo": "B3918410", + "injuryExpression": "感染征象", + "deviceFailure": "缝线张力过早丧失", + "reviewDate": "2024-08-27", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000178", + "occurrenceDate": "2025-06-13", + "registrationDate": "2025-06-24", + "unitName": "广东省人民医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进209493509", + "model": "Diacap 1.4", + "batchNo": "H1061990", + "injuryExpression": "透析中低血压", + "deviceFailure": "跨膜压波动偏大", + "reviewDate": "2025-07-01", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000179", + "occurrenceDate": "2026-02-14", + "registrationDate": "2026-02-16", + "unitName": "四川大学华西医院", 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"registrationNo": "国械注准2019280459", + "model": "Introcan 18G", + "batchNo": "K3671234", + "injuryExpression": "静脉炎", + "deviceFailure": "导管腔内回血阻力增高", + "reviewDate": "2026-03-27", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000243", + "occurrenceDate": "2025-01-21", + "registrationDate": "2025-01-25", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准209922167", + "model": "HD-180", + "batchNo": "E4950388", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2025-01-31", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000244", + "occurrenceDate": "2026-03-08", + "registrationDate": "2026-03-13", + "unitName": "上海市第一人民医院", + "businessUnit": "透析产品", + "productName": 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"saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000278", + "occurrenceDate": "2025-12-28", + "registrationDate": "2026-01-05", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进205641330", + "model": "4251624", + "batchNo": "D2297234", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2026-01-09", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000279", + "occurrenceDate": "2024-08-08", + "registrationDate": "2024-08-10", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准205435923", + "model": "IS-5.0", + "batchNo": "G3849997", + "injuryExpression": "心悸", + "deviceFailure": "流量调节轮锁止不良", + "reviewDate": "2024-08-14", + "province": "河南省", + "saeDeath": 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"province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000284", + "occurrenceDate": "2024-11-27", + "registrationDate": "2024-12-06", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2018505071", + "model": "4251624", + "batchNo": "A1182079", + "injuryExpression": "局部感染征象", + "deviceFailure": "三通接头裂纹", + "reviewDate": "2024-12-11", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000285", + "occurrenceDate": "2024-03-11", + "registrationDate": "2024-03-15", + "unitName": "四川大学华西医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2015294021", + "model": "Introcan Safety 20G", + "batchNo": "F4469258", + "injuryExpression": "红斑", + "deviceFailure": "肝素帽旋紧后微量渗液", + 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"deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2026-03-23", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000290", + "occurrenceDate": "2024-02-02", + "registrationDate": "2024-02-04", + "unitName": "天津市肿瘤医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进209234870", + "model": "Diacap 1.4", + "batchNo": "H5043678", + "injuryExpression": "出血", + "deviceFailure": "动脉端管路接头渗液", + "reviewDate": "2024-02-08", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000291", + "occurrenceDate": "2024-05-02", + "registrationDate": "2024-05-05", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注进205294729", + "model": "EX-50cm", + "batchNo": "G9970247", + "injuryExpression": 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"injuryExpression": "恶心", + "deviceFailure": "浓缩液桶盖密封条变形渗漏", + "reviewDate": "2024-05-10", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000294", + "occurrenceDate": "2025-04-14", + "registrationDate": "2025-04-25", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准208721680", + "model": "SAFE-ABG", + "batchNo": "D6854413", + "injuryExpression": "出血", + "deviceFailure": "肝素化不足标本凝固需重新采血", + "reviewDate": "2025-05-02", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000295", + "occurrenceDate": "2024-10-06", + "registrationDate": "2024-10-14", + "unitName": "南京鼓楼医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2018370344", + "model": "Monosyn 4-0", + "batchNo": "E7273216", + "injuryExpression": "出血", + "deviceFailure": "线体断裂残留", + "reviewDate": "2024-10-18", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000296", + "occurrenceDate": "2024-04-22", + "registrationDate": "2024-04-23", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准207163427", + "model": "EN-SET-1.2", + "batchNo": "C6978245", + "injuryExpression": "腹胀", + "deviceFailure": "营养袋接口与泵管连接处渗漏", + "reviewDate": "2024-04-26", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000297", + "occurrenceDate": "2024-08-08", + "registrationDate": "2024-08-10", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注进206644449", + "model": "20ml 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"injuryExpression": "寒战", + "deviceFailure": "输液管路可见异物附着", + "reviewDate": "2026-01-26", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000361", + "occurrenceDate": "2025-06-26", + "registrationDate": "2025-07-05", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注准205347698", + "model": "20ml Luer", + "batchNo": "E4216683", + "injuryExpression": "疼痛", + "deviceFailure": "推杆卡顿致推注阻力骤增", + "reviewDate": "2025-07-10", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000362", + "occurrenceDate": "2026-01-05", + "registrationDate": "2026-01-16", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进206104110", + "model": "IS-7.0", + "batchNo": "J2193741", + "injuryExpression": "心悸", + "deviceFailure": "流量调节轮锁止不良", + "reviewDate": "2026-01-23", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000363", + "occurrenceDate": "2025-12-22", + "registrationDate": "2025-12-29", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注准205111701", + "model": "10ml Luer", + "batchNo": "K4555861", + "injuryExpression": "疼痛", + "deviceFailure": "推杆卡顿致推注阻力骤增", + "reviewDate": "2026-01-01", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000364", + "occurrenceDate": "2024-01-09", + "registrationDate": "2024-01-19", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准207187750", + "model": "Diacap Pro 1.3", + "batchNo": "D5208392", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2024-01-25", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000365", + "occurrenceDate": "2024-10-30", + "registrationDate": "2024-11-08", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进205776517", + "model": "IS-5.0", + "batchNo": "A7406954", + "injuryExpression": "心悸", + "deviceFailure": "流量调节轮锁止不良", + "reviewDate": "2024-11-13", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000366", + "occurrenceDate": "2024-12-22", + "registrationDate": "2024-12-27", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进208214765", + "model": "Monosyn 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"国械注进2017415633", + "model": "PF-5.0", + "batchNo": "A2379486", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2024-11-29", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000371", + "occurrenceDate": "2025-04-07", + "registrationDate": "2025-04-08", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准207161858", + "model": "4251624", + "batchNo": "G7054200", + "injuryExpression": "红斑", + "deviceFailure": "肝素帽旋紧后微量渗液", + "reviewDate": "2025-04-11", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000372", + "occurrenceDate": "2025-10-02", + "registrationDate": "2025-10-13", + "unitName": "郑州大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2017413898", + "model": "Monosyn 4-0", + "batchNo": "C5713566", + "injuryExpression": "切口裂开", + "deviceFailure": "缝线结滑脱", + "reviewDate": "2025-10-20", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000373", + "occurrenceDate": "2024-12-31", + "registrationDate": "2025-01-07", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进2019891190", + "model": "Diacap Pro 1.3", + "batchNo": "J9308217", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2025-01-10", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000374", + "occurrenceDate": "2024-01-08", + "registrationDate": "2024-01-19", + "unitName": "广东省人民医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注进206984825", + "model": "SAFE-ABG", + "batchNo": "C8776226", + "injuryExpression": "出血", + "deviceFailure": "肝素化不足标本凝固需重新采血", + "reviewDate": "2024-01-26", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000375", + "occurrenceDate": "2024-03-03", + "registrationDate": "2024-03-11", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2018704850", + "model": "EN-SET-2.0", + "batchNo": "F7025813", + "injuryExpression": "腹泻", + "deviceFailure": "营养液温度偏低相关不适", + "reviewDate": "2024-03-15", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000376", + "occurrenceDate": "2025-10-09", + "registrationDate": "2025-10-15", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": 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false + }, + { + "reportCode": "SIM-2024-000400", + "occurrenceDate": "2024-12-14", + "registrationDate": "2024-12-25", + "unitName": "四川大学华西医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2016949375", + "model": "IS-7.0", + "batchNo": "F2404684", + "injuryExpression": "输液部位疼痛", + "deviceFailure": "滴斗液面波动异常", + "reviewDate": "2025-01-01", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000401", + "occurrenceDate": "2025-07-01", + "registrationDate": "2025-07-08", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进2015526962", + "model": "PF-7.0", + "batchNo": "H5346279", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2025-07-11", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + 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"2024-03-01", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000420", + "occurrenceDate": "2023-12-26", + "registrationDate": "2024-01-02", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进2016819401", + "model": "Monosyn 4-0", + "batchNo": "G5813447", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2024-01-05", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000421", + "occurrenceDate": "2024-03-19", + "registrationDate": "2024-03-23", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进206690040", + "model": "Diacap Pro 1.3", + "batchNo": "H9193204", + "injuryExpression": "肌肉痉挛", + "deviceFailure": "透析器外壳细微裂纹", + 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"injuryExpression": "低血压", + "deviceFailure": "过滤膜侧压力升高致滴速骤降", + "reviewDate": "2025-08-26", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000428", + "occurrenceDate": "2025-02-15", + "registrationDate": "2025-02-26", + "unitName": "中南大学湘雅医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准206344406", + "model": "Novosyn 3-0", + "batchNo": "C9323987", + "injuryExpression": "感染征象", + "deviceFailure": "缝线张力过早丧失", + "reviewDate": "2025-03-05", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000429", + "occurrenceDate": "2026-01-02", + "registrationDate": "2026-01-03", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注准2018429088", + "model": "OP-FILM-60", + "batchNo": "D8467716", + "injuryExpression": "皮肤红斑", + "deviceFailure": "粘性不足边缘翘起", + "reviewDate": "2026-01-06", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000430", + "occurrenceDate": "2024-05-20", + "registrationDate": "2024-05-21", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进2016315509", + "model": "Diacap Pro 1.3", + "batchNo": "A7989382", + "injuryExpression": "透析中低血压", + "deviceFailure": "跨膜压波动偏大", + "reviewDate": "2024-05-24", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000431", + "occurrenceDate": "2024-11-14", + "registrationDate": "2024-11-20", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进2017343947", + "model": 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"registrationNo": "国械注进206580947", + "model": "4251625", + "batchNo": "B3832989", + "injuryExpression": "局部感染征象", + "deviceFailure": "三通接头裂纹", + "reviewDate": "2025-08-22", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000438", + "occurrenceDate": "2025-07-27", + "registrationDate": "2025-08-04", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进207411944", + "model": "PF-5.0", + "batchNo": "H5431862", + "injuryExpression": "胸闷", + "deviceFailure": "侧孔进气不畅", + "reviewDate": "2025-08-08", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000439", + "occurrenceDate": "2025-09-22", + "registrationDate": "2025-10-03", + "unitName": "上海市第一人民医院", + "businessUnit": "输液治疗", + "productName": 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"productName": "可吸收性外科缝线", + "registrationNo": "国械注进207675353", + "model": "Novosyn 3-0", + "batchNo": "D7541966", + "injuryExpression": "切口裂开", + "deviceFailure": "缝线结滑脱", + "reviewDate": "2024-11-13", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000442", + "occurrenceDate": "2025-05-23", + "registrationDate": "2025-06-01", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准205771815", + "model": "IS-5.0", + "batchNo": "J4030807", + "injuryExpression": "寒战", + "deviceFailure": "输液管路可见异物附着", + "reviewDate": "2025-06-06", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000443", + "occurrenceDate": "2024-03-22", + "registrationDate": "2024-03-27", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "透析产品", 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"model": "EX-50cm", + "batchNo": "B2749758", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2025-12-26", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000507", + "occurrenceDate": "2023-12-27", + "registrationDate": "2024-01-02", + "unitName": "四川大学华西医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注进205840565", + "model": "SAFE-ABG", + "batchNo": "K6100181", + "injuryExpression": "疼痛", + "deviceFailure": "采血后桡动脉痉挛", + "reviewDate": "2024-01-10", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000508", + "occurrenceDate": "2024-09-25", + "registrationDate": "2024-09-28", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2018180582", + "model": "Introcan Safety 20G", + "batchNo": "E7806046", + "injuryExpression": "血肿", + "deviceFailure": "回血观察窗模糊影响血流判断", + "reviewDate": "2024-10-03", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000509", + "occurrenceDate": "2024-08-25", + "registrationDate": "2024-09-05", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进207455045", + "model": "IS-5.0", + "batchNo": "K6967623", + "injuryExpression": "心悸", + "deviceFailure": "流量调节轮锁止不良", + "reviewDate": "2024-09-12", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000510", + "occurrenceDate": "2025-11-17", + "registrationDate": "2025-11-28", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2018956393", + "model": "Introcan 18G", + "batchNo": "H6152769", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2025-12-05", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000511", + "occurrenceDate": "2025-04-13", + "registrationDate": "2025-04-21", + "unitName": "上海市第一人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准206134866", + "model": "EX-50cm", + "batchNo": "E4791248", + "injuryExpression": "药物输注延迟", + "deviceFailure": "延长管扭转触发流量报警", + "reviewDate": "2025-04-25", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000512", + "occurrenceDate": "2024-05-17", + "registrationDate": "2024-05-19", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": 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"productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准205595191", + "model": "PF-7.0", + "batchNo": "G5370203", + "injuryExpression": "胸闷", + "deviceFailure": "侧孔进气不畅", + "reviewDate": "2024-07-29", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000515", + "occurrenceDate": "2024-11-03", + "registrationDate": "2024-11-08", + "unitName": "中南大学湘雅医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准2019650878", + "model": "SAFE-ABG", + "batchNo": "K1513027", + "injuryExpression": "疼痛", + "deviceFailure": "采血后桡动脉痉挛", + "reviewDate": "2024-11-15", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000516", + "occurrenceDate": "2025-12-26", + "registrationDate": "2026-01-06", + "unitName": "四川大学华西医院", + "businessUnit": "透析产品", 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"businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进206605515", + "model": "HD-180", + "batchNo": "H2842840", + "injuryExpression": "头痛", + "deviceFailure": "透析液侧压力传感器报警", + "reviewDate": "2024-08-16", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000521", + "occurrenceDate": "2024-02-14", + "registrationDate": "2024-02-17", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注准2018872963", + "model": "BIC-35", + "batchNo": "B2778576", + "injuryExpression": "呕吐", + "deviceFailure": "电导度监测短暂漂移", + "reviewDate": "2024-02-22", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000522", + "occurrenceDate": "2024-02-17", + "registrationDate": "2024-02-24", + "unitName": "浙江大学医学院附属第二医院", 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"deviceFailure": "输液管路可见异物附着", + "reviewDate": "2025-12-02", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000568", + "occurrenceDate": "2025-02-05", + "registrationDate": "2025-02-15", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准205608024", + "model": "IS-5.0", + "batchNo": "G1571298", + "injuryExpression": "恶心", + "deviceFailure": "滴速过快相关不适", + "reviewDate": "2025-02-21", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000569", + "occurrenceDate": "2025-06-01", + "registrationDate": "2025-06-05", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进209814396", + "model": "4251624", + "batchNo": "K4653726", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2025-06-11", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000570", + "occurrenceDate": "2024-04-02", + "registrationDate": "2024-04-11", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注进2019657028", + "model": "10ml Luer", + "batchNo": "D5438071", + "injuryExpression": "给药剂量偏差相关不适", + "deviceFailure": "刻度印刷模糊", + "reviewDate": "2024-04-16", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000571", + "occurrenceDate": "2023-12-20", + "registrationDate": "2024-01-01", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准2017732889", + "model": "Novosyn 3-0", + "batchNo": "D7467877", + "injuryExpression": "出血", + "deviceFailure": "线体断裂残留", + "reviewDate": "2024-01-09", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000572", + "occurrenceDate": "2024-04-08", + "registrationDate": "2024-04-11", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注进2019943262", + "model": "20ml Luer", + "batchNo": "C2624880", + "injuryExpression": "给药剂量偏差相关不适", + "deviceFailure": "刻度印刷模糊", + "reviewDate": "2024-04-16", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000573", + "occurrenceDate": "2025-11-11", + "registrationDate": "2025-11-18", + "unitName": "南京鼓楼医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进208912521", + "model": "HD-180", + "batchNo": "F2828449", + "injuryExpression": "头痛", + "deviceFailure": "透析液侧压力传感器报警", + "reviewDate": "2025-11-21", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000574", + "occurrenceDate": "2025-10-12", + "registrationDate": "2025-10-22", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进2016166650", + "model": "4251625", + "batchNo": "E6848196", + "injuryExpression": "血肿", + "deviceFailure": "回血观察窗模糊影响血流判断", + "reviewDate": "2025-10-28", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000575", + "occurrenceDate": "2024-09-25", + "registrationDate": "2024-09-28", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进2015602572", + "model": "PF-7.0", + "batchNo": "H6029138", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2024-10-03", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000576", + "occurrenceDate": "2024-05-16", + "registrationDate": "2024-05-21", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进2016418484", + "model": "ACID-8L", + "batchNo": "F6155277", + "injuryExpression": "恶心", + "deviceFailure": "浓缩液桶盖密封条变形渗漏", + "reviewDate": "2024-05-28", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000577", + "occurrenceDate": "2024-11-18", + "registrationDate": "2024-11-29", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进2016118271", + "model": "IS-7.0", + "batchNo": "J7567147", + "injuryExpression": "寒战", + "deviceFailure": "输液管路可见异物附着", + "reviewDate": "2024-12-06", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000578", + "occurrenceDate": "2025-12-19", + "registrationDate": "2025-12-23", + "unitName": "广东省人民医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准2015983426", + "model": "HD-180", + "batchNo": "K4505812", + "injuryExpression": "出血", + "deviceFailure": "动脉端管路接头渗液", + "reviewDate": "2025-12-29", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000579", + "occurrenceDate": "2026-03-12", + "registrationDate": "2026-03-18", + "unitName": "上海市第一人民医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注进2016842841", + "model": "AV-SET-P", + "batchNo": "H6719975", + "injuryExpression": "失血相关血红蛋白下降", + "deviceFailure": "动脉壶液面持续下降", + "reviewDate": "2026-03-26", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000580", + "occurrenceDate": "2024-06-22", + "registrationDate": "2024-07-02", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进2017118555", + "model": "HD-180", + "batchNo": "C5414680", + "injuryExpression": "头痛", + "deviceFailure": "透析液侧压力传感器报警", + "reviewDate": "2024-07-08", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000581", + "occurrenceDate": "2025-07-30", + "registrationDate": "2025-08-08", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准205335150", + "model": "PF-5.0", + "batchNo": "F9198359", + "injuryExpression": "胸闷", + "deviceFailure": "侧孔进气不畅", + "reviewDate": "2025-08-13", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000582", + "occurrenceDate": "2025-03-17", + "registrationDate": "2025-03-18", + "unitName": "上海市第一人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2019419940", + "model": "IS-5.0", + "batchNo": "F5735623", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2025-03-21", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000583", + "occurrenceDate": "2024-03-04", + "registrationDate": "2024-03-08", + "unitName": "四川大学华西医院", + "businessUnit": "输液治疗", + "productName": "一次性使用无菌注射器", + "registrationNo": "国械注准2019464498", + "model": "10ml Luer", + "batchNo": "K7981538", + "injuryExpression": "局部肿胀", + "deviceFailure": "针头与针座连接处渗漏", + "reviewDate": "2024-03-14", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000584", + "occurrenceDate": "2025-01-27", + "registrationDate": "2025-01-28", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进208374205", + "model": "HD-180", + "batchNo": "F2731149", + "injuryExpression": "头痛", + "deviceFailure": "透析液侧压力传感器报警", + "reviewDate": "2025-01-31", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000585", + "occurrenceDate": "2025-11-20", + "registrationDate": "2025-11-23", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2019378192", + "model": "4251625", + "batchNo": "F5478940", + "injuryExpression": "瘙痒", + "deviceFailure": "延长管打折致滴速下降", + "reviewDate": "2025-11-28", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000586", + "occurrenceDate": "2024-08-22", + "registrationDate": "2024-08-27", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注准208841795", + "model": "OP-FILM-60", + "batchNo": "D1453392", + "injuryExpression": "疼痛", + "deviceFailure": "去除敷料时皮肤撕脱", + "reviewDate": "2024-09-03", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000587", + "occurrenceDate": "2026-02-18", + "registrationDate": "2026-02-23", + "unitName": "上海市第一人民医院", + "businessUnit": "输液治疗", + "productName": 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+ "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000635", + "occurrenceDate": "2025-12-08", + "registrationDate": "2025-12-09", + "unitName": "中南大学湘雅医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注准205450418", + "model": "Premilene 3-0", + "batchNo": "E3506526", + "injuryExpression": "异物感", + "deviceFailure": "线结切割组织", + "reviewDate": "2025-12-12", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000636", + "occurrenceDate": "2025-02-17", + "registrationDate": "2025-02-20", + "unitName": "中南大学湘雅医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进2016558805", + "model": "IS-7.0", + "batchNo": "D4852171", + "injuryExpression": "瘙痒", + "deviceFailure": "精密过滤器外壳裂纹", + "reviewDate": "2025-02-25", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000637", + "occurrenceDate": "2024-01-02", + "registrationDate": "2024-01-08", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进2019260772", + "model": "Novosyn 3-0", + "batchNo": "H1805457", + "injuryExpression": "感染征象", + "deviceFailure": "缝线张力过早丧失", + "reviewDate": "2024-01-16", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000638", + "occurrenceDate": "2025-04-25", + "registrationDate": "2025-05-01", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进2015241177", + "model": "4053000", + "batchNo": "E5382495", + "injuryExpression": "恶心", + "deviceFailure": "滴速过快相关不适", + "reviewDate": "2025-05-09", + 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"injuryExpression": "疼痛", + "deviceFailure": "推杆卡顿致推注阻力骤增", + "reviewDate": "2025-07-11", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000651", + "occurrenceDate": "2025-12-13", + "registrationDate": "2025-12-24", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注进206140074", + "model": "SAFE-ABG", + "batchNo": "H9158718", + "injuryExpression": "出血", + "deviceFailure": "肝素化不足标本凝固需重新采血", + "reviewDate": "2025-12-31", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000652", + "occurrenceDate": "2026-03-28", + "registrationDate": "2026-04-04", + "unitName": "中南大学湘雅医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2015644595", + "model": "IS-7.0", + 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"model": "Introcan Safety 20G", + "batchNo": "F5626881", + "injuryExpression": "穿刺部位疼痛", + "deviceFailure": "套管与导管座连接处渗漏", + "reviewDate": "2025-02-18", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000655", + "occurrenceDate": "2026-03-26", + "registrationDate": "2026-04-03", + "unitName": "广东省人民医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注准2016833286", + "model": "AV-SET-A", + "batchNo": "B1593539", + "injuryExpression": "出血", + "deviceFailure": "泵管段磨损起皱", + "reviewDate": "2026-04-07", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000656", + "occurrenceDate": "2024-01-23", + "registrationDate": "2024-01-26", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2016671141", + "model": "EN-SET-1.2", + "batchNo": "J2087452", + "injuryExpression": "呕吐", + "deviceFailure": "滴速传感器识别不稳定", + "reviewDate": "2024-01-31", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000657", + "occurrenceDate": "2025-03-13", + "registrationDate": "2025-03-24", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准209289918", + "model": "4053000", + "batchNo": "F9579441", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2025-03-31", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000658", + "occurrenceDate": "2025-09-26", + "registrationDate": "2025-10-08", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进205403503", + "model": "BIC-35", + "batchNo": "H2374275", + "injuryExpression": "恶心", + "deviceFailure": "浓缩液桶盖密封条变形渗漏", + "reviewDate": "2025-10-16", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000659", + "occurrenceDate": "2024-07-27", + "registrationDate": "2024-07-28", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准208366305", + "model": "EX-100cm", + "batchNo": "E3308323", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2024-07-31", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000660", + "occurrenceDate": "2024-12-14", + "registrationDate": "2024-12-22", + "unitName": "山东大学齐鲁医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进208104966", + "model": "Diacap Pro 1.3", + "batchNo": "E4519770", + "injuryExpression": "胸痛", + "deviceFailure": "静脉压升高报警", + "reviewDate": "2024-12-26", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000661", + "occurrenceDate": "2024-01-22", + "registrationDate": "2024-01-23", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准208346916", + "model": "PF-7.0", + "batchNo": "J2892829", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2024-01-26", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000662", + "occurrenceDate": "2025-06-15", + "registrationDate": "2025-06-18", + "unitName": "郑州大学第一附属医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注进2017738561", + "model": "SAFE-ABG", + "batchNo": "G3442227", + "injuryExpression": "出血", + "deviceFailure": "肝素化不足标本凝固需重新采血", + "reviewDate": "2025-06-23", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000663", + "occurrenceDate": "2024-01-15", + "registrationDate": "2024-01-26", + "unitName": "南京鼓楼医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注准2016897962", + "model": "ACID-8L", + "batchNo": "K8471253", + "injuryExpression": "呕吐", + "deviceFailure": "电导度监测短暂漂移", + "reviewDate": "2024-02-02", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000664", + "occurrenceDate": "2025-03-20", + "registrationDate": "2025-03-23", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": 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"injuryExpression": "水肿", + "deviceFailure": "缝针与线体连接处松动", + "reviewDate": "2025-01-10", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000710", + "occurrenceDate": "2025-11-18", + "registrationDate": "2025-11-25", + "unitName": "郑州大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进208221305", + "model": "Monosyn 4-0", + "batchNo": "K3758950", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-11-28", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000711", + "occurrenceDate": "2024-09-08", + "registrationDate": "2024-09-16", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准208891221", + "model": "Introcan 18G", + "batchNo": 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"透析液侧压力传感器报警", + "reviewDate": "2024-02-29", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000775", + "occurrenceDate": "2023-12-15", + "registrationDate": "2023-12-16", + "unitName": "上海市第一人民医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注进205199076", + "model": "Premilene 3-0", + "batchNo": "E5342684", + "injuryExpression": "异物感", + "deviceFailure": "线结切割组织", + "reviewDate": "2023-12-19", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000776", + "occurrenceDate": "2024-06-29", + "registrationDate": "2024-07-07", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进207652496", + "model": "Diacap Pro 1.3", + "batchNo": "F6503692", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2024-07-11", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000777", + "occurrenceDate": "2025-01-12", + "registrationDate": "2025-01-13", + "unitName": "天津市肿瘤医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注准208884243", + "model": "Dafilon 5-0", + "batchNo": "C5656048", + "injuryExpression": "红斑", + "deviceFailure": "缝线表面粗糙刺激", + "reviewDate": "2025-01-16", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000778", + "occurrenceDate": "2025-11-24", + "registrationDate": "2025-12-05", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准2019767397", + "model": "EX-100cm", + "batchNo": "J5082963", + "injuryExpression": "药物输注延迟", + "deviceFailure": "延长管扭转触发流量报警", + "reviewDate": "2025-12-12", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000779", + "occurrenceDate": "2025-05-18", + "registrationDate": "2025-05-19", + "unitName": "四川大学华西医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进206316847", + "model": "Diacap Pro 1.3", + "batchNo": "K6898539", + "injuryExpression": "胸痛", + "deviceFailure": "静脉压升高报警", + "reviewDate": "2025-05-22", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000780", + "occurrenceDate": "2025-11-18", + "registrationDate": "2025-11-24", + "unitName": "福建省立医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注进2017712309", + "model": "OP-FILM-60", + "batchNo": "D8185937", + "injuryExpression": "瘙痒", + "deviceFailure": "敷料下汗液积聚刺激", + "reviewDate": "2025-12-02", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000781", + "occurrenceDate": "2025-01-12", + "registrationDate": "2025-01-20", + "unitName": "广东省人民医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注准209101766", + "model": "Monosyn 4-0", + "batchNo": "F2140785", + "injuryExpression": "疼痛", + "deviceFailure": "缝针弯曲", + "reviewDate": "2025-01-24", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000782", + "occurrenceDate": "2024-11-10", + "registrationDate": "2024-11-18", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注进205664725", + "model": "EN-SET-1.2", + "batchNo": "D1779635", + "injuryExpression": "腹胀", + "deviceFailure": "营养袋接口与泵管连接处渗漏", + "reviewDate": "2024-11-22", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000783", + "occurrenceDate": "2025-05-10", + "registrationDate": "2025-05-11", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2016193152", + "model": "Introcan 18G", + "batchNo": "H5694910", + "injuryExpression": "穿刺部位疼痛", + "deviceFailure": "套管与导管座连接处渗漏", + "reviewDate": "2025-05-14", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000784", + "occurrenceDate": "2026-04-03", + "registrationDate": "2026-04-04", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进2018871273", + "model": "PF-7.0", + "batchNo": "J1634376", + "injuryExpression": "低血压", + "deviceFailure": "过滤膜侧压力升高致滴速骤降", + "reviewDate": "2026-04-07", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000785", + "occurrenceDate": "2025-03-07", + "registrationDate": "2025-03-12", + "unitName": "山东大学齐鲁医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准208880760", + "model": "ABG-3ml", + "batchNo": "C6952435", + "injuryExpression": "出血", + "deviceFailure": "肝素化不足标本凝固需重新采血", + "reviewDate": "2025-03-19", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000786", + "occurrenceDate": "2024-05-31", + "registrationDate": "2024-06-12", + "unitName": "广东省人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进207949770", + "model": "IS-5.0", + "batchNo": "E8722346", + "injuryExpression": "心悸", + "deviceFailure": "流量调节轮锁止不良", + "reviewDate": "2024-06-20", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000787", + "occurrenceDate": "2025-08-22", + "registrationDate": "2025-08-27", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进2017910344", + "model": "IS-7.0", + "batchNo": "J9044844", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2025-09-03", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000788", + "occurrenceDate": "2024-02-14", + "registrationDate": "2024-02-24", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": 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"registrationNo": "国械注进208628204", + "model": "PF-5.0", + "batchNo": "H8542147", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2024-06-04", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000793", + "occurrenceDate": "2024-09-17", + "registrationDate": "2024-09-29", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注准2016921734", + "model": "AV-SET-P", + "batchNo": "J6158170", + "injuryExpression": "寒战", + "deviceFailure": "管路预冲残留气泡", + "reviewDate": "2024-10-07", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000794", + "occurrenceDate": "2025-06-10", + "registrationDate": "2025-06-17", + "unitName": "南京鼓楼医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注进2016393202", + "model": "Dafilon 5-0", + "batchNo": "F4059450", + "injuryExpression": "水肿", + "deviceFailure": "缝针与线体连接处松动", + "reviewDate": "2025-06-20", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000795", + "occurrenceDate": "2024-11-11", + "registrationDate": "2024-11-17", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2019312500", + "model": "4251624", + "batchNo": "A3520263", + "injuryExpression": "出血", + "deviceFailure": "针尖保护装置回弹不畅", + "reviewDate": "2024-11-25", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000796", + "occurrenceDate": "2024-03-29", + "registrationDate": "2024-03-30", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": 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"输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进205452031", + "model": "PF-5.0", + "batchNo": "F6754958", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2025-05-09", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000864", + "occurrenceDate": "2024-07-25", + "registrationDate": "2024-08-05", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准209602872", + "model": "EX-100cm", + "batchNo": "J6704170", + "injuryExpression": "局部肿胀", + "deviceFailure": "接口渗液", + "reviewDate": "2024-08-12", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000865", + "occurrenceDate": "2024-06-11", + "registrationDate": "2024-06-17", + "unitName": "西安交通大学第一附属医院", + 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"2024-10-16", + "unitName": "四川大学华西医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2017675235", + "model": "EN-SET-2.0", + "batchNo": "F5582625", + "injuryExpression": "腹胀", + "deviceFailure": "营养袋接口与泵管连接处渗漏", + "reviewDate": "2024-10-21", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000872", + "occurrenceDate": "2024-05-21", + "registrationDate": "2024-05-28", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注准2018504588", + "model": "OP-FILM-60", + "batchNo": "K9655959", + "injuryExpression": "皮肤红斑", + "deviceFailure": "粘性不足边缘翘起", + "reviewDate": "2024-05-31", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000873", + "occurrenceDate": "2024-04-15", + "registrationDate": "2024-04-19", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注进207520707", + "model": "PF-7.0", + "batchNo": "E6869605", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2024-04-25", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000874", + "occurrenceDate": "2025-04-07", + "registrationDate": "2025-04-13", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进207475651", + "model": "ACID-8L", + "batchNo": "C7794838", + "injuryExpression": "呕吐", + "deviceFailure": "电导度监测短暂漂移", + "reviewDate": "2025-04-21", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000875", + "occurrenceDate": 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"saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000893", + "occurrenceDate": "2025-11-23", + "registrationDate": "2025-11-27", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准205518228", + "model": "PF-7.0", + "batchNo": "E3931099", + "injuryExpression": "低血压", + "deviceFailure": "过滤膜侧压力升高致滴速骤降", + "reviewDate": "2025-12-03", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000894", + "occurrenceDate": "2024-06-20", + "registrationDate": "2024-06-29", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进209313204", + "model": "Diacap Pro 1.3", + "batchNo": "K7429609", + "injuryExpression": "恶心", + "deviceFailure": "超滤率设置与监测不一致", + "reviewDate": "2024-07-04", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000895", + "occurrenceDate": "2025-08-26", + "registrationDate": "2025-08-30", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进207122967", + "model": "BIC-35", + "batchNo": "H5480394", + "injuryExpression": "低血压", + "deviceFailure": "透析液成分配比异常相关不适", + "reviewDate": "2025-09-05", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000896", + "occurrenceDate": "2025-09-26", + "registrationDate": "2025-10-05", + "unitName": "上海市第一人民医院", + "businessUnit": "诊断/监测耗材", + "productName": "一次性使用动脉采血器", + "registrationNo": "国械注准2016963548", + "model": "SAFE-ABG", + "batchNo": "E5013802", + "injuryExpression": "出血", + "deviceFailure": "肝素化不足标本凝固需重新采血", + "reviewDate": "2025-10-10", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000897", + "occurrenceDate": "2024-05-02", + "registrationDate": "2024-05-08", + "unitName": "天津市肿瘤医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注准205258286", + "model": "AV-SET-P", + "batchNo": "J1723391", + "injuryExpression": "寒战", + "deviceFailure": "管路预冲残留气泡", + "reviewDate": "2024-05-16", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000898", + "occurrenceDate": "2025-12-17", + "registrationDate": "2025-12-26", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准208439080", + "model": "EN-SET-2.0", + "batchNo": "H5852385", + "injuryExpression": "呕吐", + "deviceFailure": "滴速传感器识别不稳定", + "reviewDate": "2025-12-31", + "province": 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"province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000901", + "occurrenceDate": "2025-09-27", + "registrationDate": "2025-10-07", + "unitName": "广东省人民医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注准206229733", + "model": "BIC-35", + "batchNo": "D2523116", + "injuryExpression": "低血压", + "deviceFailure": "透析液成分配比异常相关不适", + "reviewDate": "2025-10-13", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000902", + "occurrenceDate": "2026-02-11", + "registrationDate": "2026-02-21", + "unitName": "天津市肿瘤医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进206958330", + "model": "BIC-35", + "batchNo": "A7828765", + "injuryExpression": "低血压", + "deviceFailure": "透析液成分配比异常相关不适", + "reviewDate": "2026-02-27", + 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"2024-09-20", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000905", + "occurrenceDate": "2024-04-21", + "registrationDate": "2024-04-25", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进209520829", + "model": "Introcan Safety 20G", + "batchNo": "G6231154", + "injuryExpression": "出血", + "deviceFailure": "针尖保护装置回弹不畅", + "reviewDate": "2024-05-01", + "province": "江苏省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000906", + "occurrenceDate": "2025-06-24", + "registrationDate": "2025-06-28", + "unitName": "郑州大学第一附属医院", + "businessUnit": "外科产品", + "productName": "非吸收性外科缝线", + "registrationNo": "国械注进207230993", + "model": "Dafilon 5-0", + "batchNo": "E7768475", + "injuryExpression": "红斑", + "deviceFailure": "缝线表面粗糙刺激", + 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"deviceFailure": "精密过滤器外壳裂纹", + "reviewDate": "2024-03-01", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000913", + "occurrenceDate": "2024-11-07", + "registrationDate": "2024-11-16", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进206619005", + "model": "Introcan Safety 20G", + "batchNo": "E9997327", + "injuryExpression": "穿刺部位疼痛", + "deviceFailure": "套管与导管座连接处渗漏", + "reviewDate": "2024-11-21", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000914", + "occurrenceDate": "2024-05-26", + "registrationDate": "2024-06-05", + "unitName": "南京鼓楼医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注进208136184", + "model": "Introcan 18G", + "batchNo": "A1970883", + 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"PF-7.0", + "batchNo": "C8532252", + "injuryExpression": "发热", + "deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2024-08-06", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000925", + "occurrenceDate": "2024-01-01", + "registrationDate": "2024-01-02", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准208326485", + "model": "HD-180", + "batchNo": "C3023122", + "injuryExpression": "肌肉痉挛", + "deviceFailure": "透析器外壳细微裂纹", + "reviewDate": "2024-01-05", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000926", + "occurrenceDate": "2024-01-24", + "registrationDate": "2024-01-27", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "外科产品", + "productName": "可吸收性外科缝线", + "registrationNo": "国械注进205534193", + 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"registrationNo": "国械注准2017323755", + "model": "OP-FILM-45", + "batchNo": "A8745468", + "injuryExpression": "皮肤红斑", + "deviceFailure": "粘性不足边缘翘起", + "reviewDate": "2024-03-15", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000933", + "occurrenceDate": "2024-06-28", + "registrationDate": "2024-07-07", + "unitName": "天津市肿瘤医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准2015507315", + "model": "EX-50cm", + "batchNo": "A5446501", + "injuryExpression": "局部肿胀", + "deviceFailure": "接口渗液", + "reviewDate": "2024-07-12", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000934", + "occurrenceDate": "2024-08-01", + "registrationDate": "2024-08-03", + "unitName": "上海市第一人民医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", 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"reviewDate": "2025-02-26", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000978", + "occurrenceDate": "2025-04-24", + "registrationDate": "2025-05-03", + "unitName": "华中科技大学同济医学院附属协和医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准209514514", + "model": "PF-5.0", + "batchNo": "C3471160", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2025-05-08", + "province": "湖北省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000979", + "occurrenceDate": "2025-05-18", + "registrationDate": "2025-05-21", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注进2017931383", + "model": "IS-7.0", + "batchNo": "E5582851", + "injuryExpression": "寒战", + "deviceFailure": 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"deviceFailure": "过滤器下游管路温度异常升高", + "reviewDate": "2025-02-13", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000982", + "occurrenceDate": "2025-08-24", + "registrationDate": "2025-08-29", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准2018704349", + "model": "EX-50cm", + "batchNo": "B3868877", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2025-09-05", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000983", + "occurrenceDate": "2025-08-17", + "registrationDate": "2025-08-24", + "unitName": "上海市第一人民医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准208928376", + "model": "Diacap 1.4", + "batchNo": "H9162937", + "injuryExpression": "出血", + "deviceFailure": "动脉端管路接头渗液", + "reviewDate": "2025-08-27", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000984", + "occurrenceDate": "2024-08-18", + "registrationDate": "2024-08-23", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准208903422", + "model": "Diacap Pro 1.3", + "batchNo": "A6129437", + "injuryExpression": "出血", + "deviceFailure": "动脉端管路接头渗液", + "reviewDate": "2024-08-30", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000985", + "occurrenceDate": "2024-11-14", + "registrationDate": "2024-11-26", + "unitName": "浙江大学医学院附属第二医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2019447546", + "model": "IS-7.0", + "batchNo": "B9439104", + "injuryExpression": "空气栓塞相关症状（已处理）", + "deviceFailure": "管路接头松动致滴管内进气", + "reviewDate": "2024-12-04", + "province": "浙江省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000986", + "occurrenceDate": "2025-06-27", + "registrationDate": "2025-06-29", + "unitName": "上海市第一人民医院", + "businessUnit": "透析产品", + "productName": "血液透析浓缩液", + "registrationNo": "国械注进205316196", + "model": "BIC-35", + "batchNo": "J5704878", + "injuryExpression": "呕吐", + "deviceFailure": "电导度监测短暂漂移", + "reviewDate": "2025-07-03", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000987", + "occurrenceDate": "2024-03-09", + "registrationDate": "2024-03-21", + "unitName": "西安交通大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2019241311", + "model": "4251624", + "batchNo": "G8803917", + "injuryExpression": "水肿", + "deviceFailure": "留置针固定翼粘贴失效", + "reviewDate": "2024-03-29", + "province": "陕西省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000988", + "occurrenceDate": "2025-01-04", + "registrationDate": "2025-01-12", + "unitName": "福建省立医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注准2016911246", + "model": "Diacap Pro 1.3", + "batchNo": "B8619211", + "injuryExpression": "肌肉痉挛", + "deviceFailure": "透析器外壳细微裂纹", + "reviewDate": "2025-01-16", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000989", + "occurrenceDate": "2025-11-20", + "registrationDate": "2025-11-23", + "unitName": "广东省人民医院", + "businessUnit": "透析产品", + "productName": "血液透析器", + "registrationNo": "国械注进2018268203", + "model": "HD-180", + "batchNo": "J5672855", + "injuryExpression": "肌肉痉挛", + "deviceFailure": "透析器外壳细微裂纹", + "reviewDate": "2025-11-28", + "province": "广东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000990", + "occurrenceDate": "2025-01-28", + "registrationDate": "2025-02-03", + "unitName": "上海市第一人民医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准205409954", + "model": "4251625", + "batchNo": "E1266590", + "injuryExpression": "静脉炎", + "deviceFailure": "导管腔内回血阻力增高", + "reviewDate": "2025-02-11", + "province": "上海市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000991", + "occurrenceDate": "2024-08-26", + "registrationDate": "2024-09-01", + "unitName": "中国医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输注延长管", + "registrationNo": "国械注准209527100", + "model": "EX-50cm", + "batchNo": "G9858929", + "injuryExpression": "输注中断相关焦虑", + "deviceFailure": "螺旋接口与泵管不匹配", + "reviewDate": "2024-09-09", + "province": "辽宁省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000992", + "occurrenceDate": "2025-11-17", + "registrationDate": "2025-11-27", + "unitName": "四川大学华西医院", + "businessUnit": "外科产品", + "productName": "一次性使用无菌手术膜", + "registrationNo": "国械注准206674870", + "model": "OP-FILM-60", + "batchNo": "C9382979", + "injuryExpression": "瘙痒", + "deviceFailure": "敷料下汗液积聚刺激", + "reviewDate": "2025-12-03", + "province": "四川省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000993", + "occurrenceDate": "2025-10-11", + "registrationDate": "2025-10-13", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2018734777", + "model": "4251624", + "batchNo": "K9882995", + "injuryExpression": "局部感染征象", + "deviceFailure": "三通接头裂纹", + "reviewDate": "2025-10-17", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000994", + "occurrenceDate": "2025-01-23", + "registrationDate": "2025-01-31", + "unitName": "中南大学湘雅医院", + "businessUnit": "输液治疗", + "productName": "一次性使用精密过滤输液器", + "registrationNo": "国械注准2016778532", + "model": "PF-7.0", + "batchNo": "A8820564", + "injuryExpression": "头痛", + "deviceFailure": "排气孔堵塞需二次排气", + "reviewDate": "2025-02-04", + "province": "湖南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000995", + "occurrenceDate": "2024-10-26", + "registrationDate": "2024-10-27", + "unitName": "重庆医科大学附属第一医院", + "businessUnit": "输液治疗", + "productName": "一次性使用静脉留置针", + "registrationNo": "国械注准2018717660", + "model": "Introcan 18G", + "batchNo": "J9861695", + "injuryExpression": "瘙痒", + "deviceFailure": "延长管打折致滴速下降", + "reviewDate": "2024-10-30", + "province": "重庆市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000996", + "occurrenceDate": "2024-08-20", + "registrationDate": "2024-08-24", + "unitName": "福建省立医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准207335947", + "model": "IS-7.0", + "batchNo": "A8598480", + "injuryExpression": "渗漏致皮肤红斑", + "deviceFailure": "穿刺器与药瓶胶塞密封不严", + "reviewDate": "2024-08-30", + "province": "福建省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000997", + "occurrenceDate": "2024-08-18", + "registrationDate": "2024-08-26", + "unitName": "郑州大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2017182503", + "model": "4053000", + "batchNo": "J7354708", + "injuryExpression": "恶心", + "deviceFailure": "滴速过快相关不适", + "reviewDate": "2024-08-30", + "province": "河南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000998", + "occurrenceDate": "2025-06-16", + "registrationDate": "2025-06-17", + "unitName": "山东大学齐鲁医院", + "businessUnit": "输液治疗", + "productName": "一次性使用输液器", + "registrationNo": "国械注准2015229379", + "model": "IS-5.0", + "batchNo": "A7577034", + "injuryExpression": "输液部位疼痛", + "deviceFailure": "滴斗液面波动异常", + "reviewDate": "2025-06-20", + "province": "山东省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-000999", + "occurrenceDate": "2024-01-03", + "registrationDate": "2024-01-11", + "unitName": "昆明医科大学第一附属医院", + "businessUnit": "输液治疗", + "productName": "一次性使用肠内营养输液器", + "registrationNo": "国械注准2018843612", + "model": "EN-SET-2.0", + "batchNo": "D1024896", + "injuryExpression": "腹泻", + "deviceFailure": "营养液温度偏低相关不适", + "reviewDate": "2024-01-15", + "province": "云南省", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + }, + { + "reportCode": "SIM-2024-001000", + "occurrenceDate": "2024-07-20", + "registrationDate": "2024-08-01", + "unitName": "天津市肿瘤医院", + "businessUnit": "透析产品", + "productName": "血液透析管路", + "registrationNo": "国械注准2017375062", + "model": "AV-SET-A", + "batchNo": "A8997713", + "injuryExpression": "失血相关血红蛋白下降", + "deviceFailure": "动脉壶液面持续下降", + "reviewDate": "2024-08-09", + "province": "天津市", + "saeDeath": false, + "saeLifeThreatening": false, + "saeDisability": false, + "saeHospitalization": false + } +] \ No newline at end of file diff --git a/analytics-demo-web/public/mock/complaint.json b/analytics-demo-web/public/mock/complaint.json new file mode 100644 index 0000000..fe1f7c0 --- /dev/null +++ b/analytics-demo-web/public/mock/complaint.json @@ -0,0 +1,14002 @@ +[ + { + "c3Code": "C3-2026-000001", + "model": "AV-SET-P", + "batchNo": "A7016582", + "registrationNo": "国械注进2016421013", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2024-12-11", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-02-07" + }, + { + "c3Code": "C3-2026-000002", + "model": "5-0", + "batchNo": "B8178540", + "registrationNo": "国械注进2026157995", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2025-07-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2025-07-11" + }, + { + "c3Code": "C3-2026-000003", + "model": "IS-7.0", + "batchNo": "G2515397", + "registrationNo": "国械注进2020836091", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2024-03-19", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-04-03" + }, + { + "c3Code": "C3-2026-000004", + "model": "1.4m²", + "batchNo": "E4358275", + "registrationNo": "国械注进2022721451", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2025-11-13", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-12-14" + }, + { + "c3Code": "C3-2026-000005", + "model": "20G", + "batchNo": "G7190068", + "registrationNo": "国械注进2016528508", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "渗漏", + "registerDate": "2026-01-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2026-01-14" + }, + { + "c3Code": "C3-2026-000006", + "model": "IS-7.0", + "batchNo": "B5355613", + "registrationNo": "国械注进2016859309", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-08-20", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-10-26" + }, + { + "c3Code": "C3-2026-000007", + "model": "AV-SET-A", + "batchNo": "F6299310", + "registrationNo": "国械注进2018267284", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2024-09-27", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-11-01" + }, + { + "c3Code": "C3-2026-000008", + "model": "5-0", + "batchNo": "H6434026", + "registrationNo": "国械注进2024648043", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-06-04", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-08-08" + }, + { + "c3Code": "C3-2026-000009", + "model": "Introcan Safety 20G", + "batchNo": "H5798932", + "registrationNo": "国械注进2017524868", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2024-06-24", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-08-07" + }, + { + "c3Code": "C3-2026-000010", + "model": "3-0", + "batchNo": "B9442408", + "registrationNo": "国械注进2022782044", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2025-10-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-11-08" + }, + { + "c3Code": "C3-2026-000011", + "model": "IS-7.0", + "batchNo": "F8382829", + "registrationNo": "国械注进2022528453", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2025-08-01", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2025-08-01" + }, + { + "c3Code": "C3-2026-000012", + "model": "AV-SET-A", + "batchNo": "D6893513", + "registrationNo": "国械注进2017386864", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2023-10-14", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2023-11-14" + }, + { + "c3Code": "C3-2026-000013", + "model": "HD-180", + "batchNo": "G4850942", + "registrationNo": "国械注进2015133195", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2025-06-09", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-07-07" + }, + { + "c3Code": "C3-2026-000014", + "model": "22G", + "batchNo": "G6170862", + "registrationNo": "国械注进2019481637", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2025-10-27", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-10-27" + }, + { + "c3Code": "C3-2026-000015", + "model": "IS-5.0", + "batchNo": "A7373528", + "registrationNo": "国械注进2024811411", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2024-09-05", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-10-02" + }, + { + "c3Code": "C3-2026-000016", + "model": "4-0", + "batchNo": "C7561784", + "registrationNo": "国械注进2017674933", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2023-12-25", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-01-10" + }, + { + "c3Code": "C3-2026-000017", + "model": "Introcan Safety 20G", + "batchNo": "G7469426", + "registrationNo": "国械注进2017162044", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2024-12-07", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-12-16" + }, + { + "c3Code": "C3-2026-000018", + "model": "4-0", + "batchNo": "E3889555", + "registrationNo": "国械注进2025177495", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "包装破损", + "registerDate": "2025-07-09", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-07-27" + }, + { + "c3Code": "C3-2026-000019", + "model": "AV-SET-A", + "batchNo": "G9067440", + "registrationNo": "国械注进2026583030", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-05-24", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-06-05" + }, + { + "c3Code": "C3-2026-000020", + "model": "5-0", + "batchNo": "F4906668", + "registrationNo": "国械注进2024860883", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2026-04-12", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2026-05-25" + }, + { + "c3Code": "C3-2026-000021", + "model": "AV-SET-A", + "batchNo": "F1843179", + "registrationNo": "国械注进2016662077", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-08-23", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-09-27" + }, + { + "c3Code": "C3-2026-000022", + "model": "20G", + "batchNo": "A6333072", + "registrationNo": "国械注进2017452903", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2025-10-29", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-12-02" + }, + { + "c3Code": "C3-2026-000023", + "model": "IS-7.0", + "batchNo": "F9124850", + "registrationNo": "国械注进2016269787", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2026-01-08", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2026-02-05" + }, + { + "c3Code": "C3-2026-000024", + "model": "24G", + "batchNo": "A9825592", + "registrationNo": "国械注进2015458874", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2025-03-12", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-04-24" + }, + { + "c3Code": "C3-2026-000025", + "model": "HD-180", + "batchNo": "H2463094", + "registrationNo": "国械注进2016709453", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2024-04-27", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-05-26" + }, + { + "c3Code": "C3-2026-000026", + "model": "PF-5.0", + "batchNo": "H9134559", + "registrationNo": "国械注进2017804695", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2026-03-23", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2026-05-05" + }, + { + "c3Code": "C3-2026-000027", + "model": "24G", + "batchNo": "F2097740", + "registrationNo": "国械注进2025399520", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2025-03-02", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-04-07" + }, + { + "c3Code": "C3-2026-000028", + "model": "24G", + "batchNo": "H2273237", + "registrationNo": "国械注进2017570206", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2023-12-16", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-12-16" + }, + { + "c3Code": "C3-2026-000029", + "model": "AV-SET-P", + "batchNo": "F5697192", + "registrationNo": "国械注进2016596818", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2025-07-08", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-08-17" + }, + { + "c3Code": "C3-2026-000030", + "model": "PF-5.0", + "batchNo": "E3246335", + "registrationNo": "国械注进2022601878", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2024-07-26", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-08-30" + }, + { + "c3Code": "C3-2026-000031", + "model": "PF-5.0", + "batchNo": "B2473406", + "registrationNo": "国械注进2020368573", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2023-10-05", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-11-13" + }, + { + "c3Code": "C3-2026-000032", + "model": "Introcan Safety 20G", + "batchNo": "H1833120", + "registrationNo": "国械注进2020408241", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2023-11-03", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-11-30" + }, + { + "c3Code": "C3-2026-000033", + "model": "3-0", + "batchNo": "C9202722", + "registrationNo": "国械注进2019375162", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "断裂", + "registerDate": "2025-01-23", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-01" + }, + { + "c3Code": "C3-2026-000034", + "model": "IS-7.0", + "batchNo": "E6949784", + "registrationNo": "国械注进2025947550", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2025-01-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-01-27" + }, + { + "c3Code": "C3-2026-000035", + "model": "22G", + "batchNo": "D5714319", + "registrationNo": "国械注进2017268390", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-07-31", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-08-17" + }, + { + "c3Code": "C3-2026-000036", + "model": "24G", + "batchNo": "D2327133", + "registrationNo": "国械注进2016581911", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2023-08-24", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-09-14" + }, + { + "c3Code": "C3-2026-000037", + "model": "PF-5.0", + "batchNo": "F6552954", + "registrationNo": "国械注进2019253129", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-06-04", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-07-06" + }, + { + "c3Code": "C3-2026-000038", + "model": "20G", + "batchNo": "D7001053", + "registrationNo": "国械注进2021969192", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2024-10-29", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-11-15" + }, + { + "c3Code": "C3-2026-000039", + "model": "IS-5.0", + "batchNo": "B6602814", + "registrationNo": "国械注进2026647928", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "标签不清", + "registerDate": "2023-10-06", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2023-11-09" + }, + { + "c3Code": "C3-2026-000040", + "model": "PF-5.0", + "batchNo": "H7781006", + "registrationNo": "国械注进2024283090", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2024-04-05", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-05-08" + }, + { + "c3Code": "C3-2026-000041", + "model": "AV-SET-A", + "batchNo": "A4359128", + "registrationNo": "国械注进2022176740", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2026-04-03", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2026-04-25" + }, + { + "c3Code": "C3-2026-000042", + "model": "IS-5.0", + "batchNo": "C6016516", + "registrationNo": "国械注进2017715058", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2024-02-08", + "isAe": 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false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-06-06" + }, + { + "c3Code": "C3-2026-000046", + "model": "4-0", + "batchNo": "D2265889", + "registrationNo": "国械注进2020779526", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2024-03-12", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-03-31" + }, + { + "c3Code": "C3-2026-000047", + "model": "AV-SET-P", + "batchNo": "E2968233", + "registrationNo": "国械注进2016272564", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-05-22", + "isAe": true, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-06-30" + }, + { + "c3Code": "C3-2026-000048", + "model": "AV-SET-A", + "batchNo": "A1345625", + "registrationNo": "国械注进2019841805", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2024-05-21", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-07-17" + }, + { + "c3Code": "C3-2026-000049", + "model": "PF-5.0", + "batchNo": "G3857224", + "registrationNo": "国械注进2021612014", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-05-15", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-05-15" + }, + { + "c3Code": "C3-2026-000050", + "model": "HD-180", + "batchNo": "H7724607", + "registrationNo": "国械注进2023161798", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2023-10-12", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2023-10-28" + }, + { + "c3Code": "C3-2026-000051", + "model": "AV-SET-P", + "batchNo": "B3648973", + "registrationNo": "国械注进2015498773", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2023-11-04", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2023-12-07" + }, + { + "c3Code": "C3-2026-000052", + "model": "4-0", + "batchNo": "C1826118", + "registrationNo": "国械注进2022205919", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2024-04-01", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-04-25" + }, + { + "c3Code": "C3-2026-000053", + "model": "1.4m²", + "batchNo": "D3105756", + "registrationNo": "国械注进2023996687", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2024-02-10", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-02-27" + }, + { + "c3Code": "C3-2026-000054", + "model": "20G", + "batchNo": "G9679823", + "registrationNo": "国械注进2022230700", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2025-02-05", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-03-22" + }, + { + "c3Code": "C3-2026-000055", + "model": "PF-5.0", + "batchNo": "B6060003", + "registrationNo": "国械注进2019306258", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2025-06-13", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-06-13" + }, + { + "c3Code": "C3-2026-000056", + "model": "HD-180", + "batchNo": "B2713881", + "registrationNo": "国械注进2019416762", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2024-01-22", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-02-22" + }, + { + "c3Code": "C3-2026-000057", + "model": "IS-7.0", + "batchNo": "C2172112", + "registrationNo": "国械注进2023617215", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2025-07-02", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-08-06" + }, + { + "c3Code": "C3-2026-000058", + "model": "24G", + "batchNo": "H5857947", + "registrationNo": "国械注进2015950001", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-01-26", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-03-05" + }, + { + "c3Code": "C3-2026-000059", + "model": "1.4m²", + "batchNo": "F9563968", + "registrationNo": "国械注进2022863396", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2023-12-01", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-01-29" + }, + { + "c3Code": "C3-2026-000060", + "model": "AV-SET-P", + "batchNo": "A7270373", + "registrationNo": "国械注进2022822763", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2025-08-27", + "isAe": false, + "conclusion": 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"compensation": "折让", + "closeDate": "2025-10-27" + }, + { + "c3Code": "C3-2026-000064", + "model": "20G", + "batchNo": "G2590607", + "registrationNo": "国械注进2022570959", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2025-07-07", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-08-10" + }, + { + "c3Code": "C3-2026-000065", + "model": "1.4m²", + "batchNo": "G3672536", + "registrationNo": "国械注进2024519719", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "连接不牢", + "registerDate": "2025-05-10", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-06-29" + }, + { + "c3Code": "C3-2026-000066", + "model": "PF-5.0", + "batchNo": "F3052104", + "registrationNo": "国械注进2017414432", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "流速异常", + "registerDate": "2025-04-03", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-05-10" + }, + { + "c3Code": "C3-2026-000067", + "model": "1.3m²", + "batchNo": "H9671033", + "registrationNo": "国械注进2019557540", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2025-04-29", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-06-05" + }, + { + "c3Code": "C3-2026-000068", + "model": "AV-SET-A", + "batchNo": "A7678668", + "registrationNo": "国械注进2019265356", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2026-03-28", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-05-19" + }, + { + "c3Code": "C3-2026-000069", + "model": "PF-5.0", + "batchNo": "B7687980", + "registrationNo": "国械注进2023310264", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2023-12-08", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-12-22" + }, + { + "c3Code": "C3-2026-000070", + "model": "3-0", + "batchNo": "E9478762", + "registrationNo": "国械注进2015345844", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "包装破损", + "registerDate": "2025-07-29", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2025-09-07" + }, + { + "c3Code": "C3-2026-000071", + "model": "PF-5.0", + "batchNo": "B7041420", + "registrationNo": "国械注进2020661075", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2026-01-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2026-01-28" + }, + { + "c3Code": "C3-2026-000072", + "model": "24G", + "batchNo": "H1467478", + "registrationNo": "国械注进2021520030", + "productName": "一次性使用静脉留置针", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2024-12-02", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-01-13" + }, + { + "c3Code": "C3-2026-000073", + "model": "AV-SET-P", + "batchNo": "H2330135", + "registrationNo": "国械注进2015868364", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-05-10", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-06-12" + }, + { + "c3Code": "C3-2026-000074", + "model": "IS-5.0", + "batchNo": "A7129537", + "registrationNo": "国械注进2015574081", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2024-01-24", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-03-24" + }, + { + "c3Code": "C3-2026-000075", + "model": "IS-5.0", + "batchNo": "B4869438", + "registrationNo": "国械注进2020723439", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2024-12-07", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2024-12-21" + }, + { + "c3Code": "C3-2026-000076", + "model": "20G", + "batchNo": "D1447091", + "registrationNo": "国械注进2022651135", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2026-03-31", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2026-03-31" + }, + { + "c3Code": "C3-2026-000077", + "model": "AV-SET-A", + "batchNo": "E1728172", + "registrationNo": "国械注进2022106199", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2024-06-19", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-07-03" + }, + { + "c3Code": "C3-2026-000078", + "model": "4-0", + "batchNo": "G7525562", + "registrationNo": "国械注进2018457631", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2025-02-21", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-02-21" + }, + { + "c3Code": "C3-2026-000079", + "model": "AV-SET-A", + "batchNo": "E1562955", + "registrationNo": "国械注进2023679069", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2023-10-14", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-10-27" + }, + { + "c3Code": "C3-2026-000080", + "model": "3-0", + "batchNo": "H7886012", + "registrationNo": "国械注进2026354277", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2025-01-18", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-03-11" + }, + { + "c3Code": "C3-2026-000081", + "model": "24G", + "batchNo": "E6196593", + "registrationNo": "国械注进2016109208", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2023-09-17", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2023-10-31" + }, + { + "c3Code": "C3-2026-000082", + "model": "HD-180", + "batchNo": "H1105218", + "registrationNo": "国械注进2017974797", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2023-08-25", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-09-27" + }, + { + "c3Code": "C3-2026-000083", + "model": "3-0", + "batchNo": "F8412706", + "registrationNo": "国械注进2021696368", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2025-03-16", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-03-29" + }, + { + "c3Code": "C3-2026-000084", + "model": "PF-5.0", + "batchNo": "C9616933", + "registrationNo": "国械注进2024923585", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-08-31", + "isAe": true, + "conclusion": "未复现", + "compensation": 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+ "closeDate": "2025-08-22" + }, + { + "c3Code": "C3-2026-000088", + "model": "AV-SET-A", + "batchNo": "G2434377", + "registrationNo": "国械注进2026346506", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2024-05-22", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-07-05" + }, + { + "c3Code": "C3-2026-000089", + "model": "22G", + "batchNo": "E7085618", + "registrationNo": "国械注进2019113081", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2026-01-29", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2026-02-02" + }, + { + "c3Code": "C3-2026-000090", + "model": "5-0", + "batchNo": "H5702908", + "registrationNo": "国械注进2019348032", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2023-11-19", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2023-12-27" + }, + { + "c3Code": "C3-2026-000091", + "model": "AV-SET-P", + "batchNo": "D9358575", + "registrationNo": "国械注进2025756901", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2025-07-17", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-07-17" + }, + { + "c3Code": "C3-2026-000092", + "model": "1.4m²", + "batchNo": "C7697626", + "registrationNo": "国械注进2024894957", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2024-05-15", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2024-05-23" + }, + { + "c3Code": "C3-2026-000093", + "model": "HD-180", + "batchNo": "E2466426", + "registrationNo": "国械注进2016905840", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2024-08-25", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-08-31" + }, + { + "c3Code": "C3-2026-000094", + "model": "AV-SET-P", + "batchNo": "H4877496", + "registrationNo": "国械注进2020923191", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2023-08-26", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2023-09-10" + }, + { + "c3Code": "C3-2026-000095", + "model": "AV-SET-A", + "batchNo": "H4029906", + "registrationNo": "国械注进2021977109", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2025-01-10", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-02-21" + }, + { + "c3Code": "C3-2026-000096", + "model": "3-0", + "batchNo": "E4963387", + "registrationNo": "国械注进2026450046", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-05-03", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-06-04" + }, + { + "c3Code": "C3-2026-000097", + "model": "4-0", + "batchNo": "A9267962", + "registrationNo": "国械注进2018155690", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2024-09-05", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-10-28" + }, + { + "c3Code": "C3-2026-000098", + "model": "3-0", + "batchNo": "D5974043", + "registrationNo": "国械注进2021269851", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-04-10", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-05-21" + }, + { + "c3Code": "C3-2026-000099", + "model": "PF-5.0", + "batchNo": "C2363042", + "registrationNo": "国械注进2024704541", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "标签不清", + "registerDate": "2026-02-19", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2026-04-07" + }, + { + "c3Code": "C3-2026-000100", + "model": "PF-5.0", + "batchNo": "H3752308", + "registrationNo": "国械注进2015146565", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2024-02-10", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-02-16" + }, + { + "c3Code": "C3-2026-000101", + "model": "HD-180", + "batchNo": "H3333472", + "registrationNo": "国械注进2026639679", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2024-04-08", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-05-15" + }, + { + "c3Code": "C3-2026-000102", + "model": "IS-5.0", + "batchNo": "B4666919", + "registrationNo": "国械注进2019971240", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2024-08-28", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-10-16" + }, + { + "c3Code": "C3-2026-000103", + "model": "HD-180", + "batchNo": "G1908920", + "registrationNo": "国械注进2022966984", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2026-02-03", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-04-13" + }, + { + "c3Code": "C3-2026-000104", + "model": "AV-SET-A", + "batchNo": "E7320616", + "registrationNo": "国械注进2023922167", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2025-01-19", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-19" + }, + { + "c3Code": "C3-2026-000105", + "model": "HD-180", + "batchNo": "H7254432", + "registrationNo": "国械注进2016706084", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2023-08-16", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2023-09-20" + }, + { + "c3Code": "C3-2026-000106", + "model": "1.4m²", + "batchNo": "H2341526", + "registrationNo": "国械注进2016791529", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2024-10-07", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-10-31" + }, + { + "c3Code": "C3-2026-000107", + "model": "AV-SET-P", + "batchNo": "B2599089", + "registrationNo": "国械注进2019244917", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2026-01-09", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2026-02-18" + }, + { + "c3Code": "C3-2026-000108", + "model": "3-0", + "batchNo": "E8365849", + "registrationNo": "国械注进2024279252", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2025-04-07", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2025-05-19" + }, + { + "c3Code": "C3-2026-000109", + "model": "AV-SET-A", + "batchNo": "A8019146", + "registrationNo": "国械注进2019923068", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2024-03-25", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-04-15" + }, + { + "c3Code": "C3-2026-000110", + "model": "PF-5.0", + "batchNo": "F7045530", + "registrationNo": "国械注进2021463455", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2023-10-05", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2023-12-09" + }, + { + "c3Code": "C3-2026-000111", + "model": "Introcan Safety 20G", + "batchNo": "B7960880", + "registrationNo": "国械注进2017688778", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2024-05-16", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-06-15" + }, + { + "c3Code": 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"c3Code": "C3-2026-000115", + "model": "4-0", + "batchNo": "E5429963", + "registrationNo": "国械注进2016723678", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2025-01-23", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-01-23" + }, + { + "c3Code": "C3-2026-000116", + "model": "PF-5.0", + "batchNo": "D7398496", + "registrationNo": "国械注进2025328228", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2023-12-11", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-12-17" + }, + { + "c3Code": "C3-2026-000117", + "model": "20G", + "batchNo": "D8907723", + "registrationNo": "国械注进2024725743", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2025-03-27", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-04-15" + }, + { + "c3Code": "C3-2026-000118", + "model": "1.4m²", + "batchNo": "H7637864", + "registrationNo": "国械注进2025956697", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2025-10-10", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-11-13" + }, + { + "c3Code": "C3-2026-000119", + "model": "4-0", + "batchNo": "B4451108", + "registrationNo": "国械注进2020206026", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2024-10-21", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-11-19" + }, + { + "c3Code": "C3-2026-000120", + "model": "4-0", + "batchNo": "C8922658", + "registrationNo": "国械注进2026313703", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2025-01-17", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-02-26" + }, + { + "c3Code": 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"C3-2026-000124", + "model": "AV-SET-A", + "batchNo": "A3964429", + "registrationNo": "国械注进2018231235", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2025-12-05", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-12-05" + }, + { + "c3Code": "C3-2026-000125", + "model": "3-0", + "batchNo": "H4855100", + "registrationNo": "国械注进2022196953", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2024-02-02", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-03-17" + }, + { + "c3Code": "C3-2026-000126", + "model": "IS-5.0", + "batchNo": "D2100397", + "registrationNo": "国械注进2023183123", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2024-01-02", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-02-14" + }, + { + "c3Code": "C3-2026-000127", + "model": "HD-180", + "batchNo": "G5720951", + "registrationNo": "国械注进2023444087", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2024-03-07", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-04-04" + }, + { + "c3Code": "C3-2026-000128", + "model": "3-0", + "batchNo": "G4971584", + "registrationNo": "国械注进2015311146", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2024-01-26", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-26" + }, + { + "c3Code": "C3-2026-000129", + "model": "22G", + "batchNo": "H8706826", + "registrationNo": "国械注进2020829671", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "包装破损", + "registerDate": "2023-09-23", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2023-10-09" + }, + { + "c3Code": "C3-2026-000130", + "model": "AV-SET-P", + "batchNo": "C4608580", + "registrationNo": "国械注进2015388792", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2023-11-27", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2023-12-17" + }, + { + "c3Code": "C3-2026-000131", + "model": "AV-SET-A", + "batchNo": "G8683691", + "registrationNo": "国械注进2022721685", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2026-04-08", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2026-06-07" + }, + { + "c3Code": "C3-2026-000132", + "model": "22G", + "batchNo": "A7479048", + "registrationNo": "国械注进2019982229", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2024-11-27", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-12-30" + }, + { + "c3Code": "C3-2026-000133", + "model": "Introcan Safety 20G", + "batchNo": "A2410583", + "registrationNo": "国械注进2016101320", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "包装破损", + "registerDate": "2023-11-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-11-07" + }, + { + "c3Code": "C3-2026-000134", + "model": "5-0", + "batchNo": "D8865707", + "registrationNo": "国械注进2024834083", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2026-02-28", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-04-11" + }, + { + "c3Code": "C3-2026-000135", + "model": "1.3m²", + "batchNo": "F3668970", + "registrationNo": "国械注进2026952080", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2025-06-08", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-06-08" + }, + { + "c3Code": "C3-2026-000136", + "model": "1.4m²", + "batchNo": "C7008490", + "registrationNo": "国械注进2024558979", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2024-01-23", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-03-14" + }, + { + "c3Code": "C3-2026-000137", + "model": "AV-SET-P", + "batchNo": "H8940355", + "registrationNo": "国械注进2026307736", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "渗漏", + "registerDate": "2026-01-18", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-01-25" + }, + { + "c3Code": "C3-2026-000138", + "model": "1.3m²", + "batchNo": "D7661913", + "registrationNo": "国械注进2023593121", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2023-11-23", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2023-12-24" + }, + { + "c3Code": "C3-2026-000139", + "model": "Introcan Safety 20G", + "batchNo": "C8240929", + "registrationNo": "国械注进2022942524", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "包装破损", + "registerDate": "2024-08-07", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-08-27" + }, + { + "c3Code": "C3-2026-000140", + "model": "IS-7.0", + "batchNo": "D1364828", + "registrationNo": "国械注进2022620586", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2025-03-18", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-03-18" + }, + { + "c3Code": "C3-2026-000141", + "model": "HD-180", + "batchNo": "B9915053", + "registrationNo": "国械注进2025420920", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2023-10-03", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-10-15" + }, + { + "c3Code": "C3-2026-000142", + "model": "22G", + "batchNo": "E9184077", + "registrationNo": "国械注进2019704302", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2023-10-07", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2023-11-20" + }, + { + "c3Code": "C3-2026-000143", + "model": "AV-SET-A", + "batchNo": "E6797083", + "registrationNo": "国械注进2025963235", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2025-02-14", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-03-30" + }, + { + "c3Code": "C3-2026-000144", + "model": "1.3m²", + "batchNo": "H9004014", + "registrationNo": "国械注进2015760050", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2025-12-15", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-01-20" + }, + { + "c3Code": "C3-2026-000145", + "model": "4-0", + "batchNo": "C8516036", + "registrationNo": "国械注进2024707512", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2025-03-15", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-04-06" + }, + { + "c3Code": "C3-2026-000146", + "model": "3-0", + "batchNo": "A5325588", + "registrationNo": "国械注进2023632929", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2023-10-26", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-12-15" + }, + { + "c3Code": "C3-2026-000147", + "model": "AV-SET-A", + "batchNo": "E4945208", + "registrationNo": "国械注进2015887620", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2024-05-10", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-07-11" + }, + { + "c3Code": "C3-2026-000148", + "model": "1.4m²", + "batchNo": "F1703475", + "registrationNo": "国械注进2024156773", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2024-07-20", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-09-03" + }, + { + "c3Code": "C3-2026-000149", + "model": "1.4m²", + "batchNo": "A3725332", + "registrationNo": "国械注进2023847651", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2024-03-29", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-04-13" + }, + { + "c3Code": "C3-2026-000150", + "model": "PF-5.0", + "batchNo": "D8698780", + "registrationNo": "国械注进2020612187", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2025-03-02", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2025-03-24" + }, + { + "c3Code": "C3-2026-000151", + "model": "IS-5.0", + "batchNo": "A7489262", + "registrationNo": "国械注进2020915779", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "标签不清", + "registerDate": "2026-01-26", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-01-26" + }, + { + "c3Code": "C3-2026-000152", + "model": "20G", + "batchNo": "G3986842", + "registrationNo": "国械注进2025591367", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "流速异常", + "registerDate": "2023-11-21", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-01-26" + }, + { + "c3Code": "C3-2026-000153", + "model": "1.4m²", + "batchNo": "D1654577", + "registrationNo": "国械注进2018615356", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "断裂", + "registerDate": "2024-01-12", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-12" + }, + { + "c3Code": "C3-2026-000154", + "model": "4-0", + "batchNo": "E5342363", + "registrationNo": "国械注进2017779649", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2025-07-27", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-08-19" + }, + { + "c3Code": "C3-2026-000155", + "model": "22G", + "batchNo": "B6728664", + "registrationNo": "国械注进2018867902", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-02-13", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-03-30" + }, + { + "c3Code": "C3-2026-000156", + "model": "24G", + "batchNo": "B4573402", + "registrationNo": "国械注进2024680080", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-05-07", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-06-18" + }, + { + "c3Code": "C3-2026-000157", + "model": "3-0", + "batchNo": "E7598305", + "registrationNo": "国械注进2023989271", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-09-01", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-09-26" + }, + { + "c3Code": "C3-2026-000158", + "model": "PF-5.0", + "batchNo": "E7286905", + "registrationNo": "国械注进2015984579", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2025-07-23", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-09-17" + }, + { + "c3Code": "C3-2026-000159", + "model": "3-0", + "batchNo": "E2185707", + "registrationNo": "国械注进2020644342", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2025-12-02", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2026-01-02" + }, + { + "c3Code": "C3-2026-000160", + "model": 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"batchNo": "E1051554", + "registrationNo": "国械注进2023589963", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2023-12-31", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2024-03-07" + }, + { + "c3Code": "C3-2026-000164", + "model": "Introcan Safety 20G", + "batchNo": "H9800784", + "registrationNo": "国械注进2022247742", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2023-09-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-09-11" + }, + { + "c3Code": "C3-2026-000165", + "model": "AV-SET-P", + "batchNo": "C1919113", + "registrationNo": "国械注进2020662481", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2023-10-05", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-11-10" + }, + { + "c3Code": "C3-2026-000166", + "model": 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"1.3m²", + "batchNo": "C2353972", + "registrationNo": "国械注进2022629975", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2023-10-31", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-11-21" + }, + { + "c3Code": "C3-2026-000176", + "model": "3-0", + "batchNo": "G1365397", + "registrationNo": "国械注进2020366216", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2024-10-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-10-30" + }, + { + "c3Code": "C3-2026-000177", + "model": "1.3m²", + "batchNo": "E3849810", + "registrationNo": "国械注进2015501278", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2026-01-14", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2026-02-05" + }, + { + "c3Code": "C3-2026-000178", + "model": "4-0", + "batchNo": 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"registrationNo": "国械注进2020864107", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2023-11-04", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-11-20" + }, + { + "c3Code": "C3-2026-000188", + "model": "AV-SET-A", + "batchNo": "C4119902", + "registrationNo": "国械注进2019910001", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2025-05-24", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-06-01" + }, + { + "c3Code": "C3-2026-000189", + "model": "4-0", + "batchNo": "E1931406", + "registrationNo": "国械注进2019691861", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2025-03-13", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-03-17" + }, + { + "c3Code": "C3-2026-000190", + "model": "Introcan Safety 20G", + "batchNo": "A3688120", 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"registrationNo": "国械注进2016307586", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "连接不牢", + "registerDate": "2024-09-23", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-10-06" + }, + { + "c3Code": "C3-2026-000194", + "model": "20G", + "batchNo": "D7358110", + "registrationNo": "国械注进2016386905", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2025-03-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-03-24" + }, + { + "c3Code": "C3-2026-000195", + "model": "1.3m²", + "batchNo": "E5304325", + "registrationNo": "国械注进2022879987", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2025-11-15", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-11-15" + }, + { + "c3Code": "C3-2026-000196", + "model": "Introcan Safety 20G", + "batchNo": "G2815359", 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"registrationNo": "国械注进2022988842", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-10-30", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-12-11" + }, + { + "c3Code": "C3-2026-000215", + "model": "24G", + "batchNo": "E6174326", + "registrationNo": "国械注进2019892249", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2023-08-09", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-08-29" + }, + { + "c3Code": "C3-2026-000216", + "model": "4-0", + "batchNo": "B3751788", + "registrationNo": "国械注进2022312376", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2024-09-08", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-11-04" + }, + { + "c3Code": "C3-2026-000217", + "model": "AV-SET-A", + "batchNo": "D6763196", + "registrationNo": "国械注进2022330415", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2024-07-26", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-09-11" + }, + { + "c3Code": "C3-2026-000218", + "model": "AV-SET-P", + "batchNo": "H5040289", + "registrationNo": "国械注进2019867821", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "堵塞", + "registerDate": "2024-12-03", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-01-15" + }, + { + "c3Code": "C3-2026-000219", + "model": "AV-SET-P", + "batchNo": "H2049394", + "registrationNo": "国械注进2016209770", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2024-01-04", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-01-20" + }, + { + "c3Code": "C3-2026-000220", + "model": "22G", + "batchNo": "A6089578", + "registrationNo": "国械注进2019156496", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2025-06-02", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-07-19" + }, + { + "c3Code": "C3-2026-000221", + "model": "AV-SET-P", + "batchNo": "A7239022", + "registrationNo": "国械注进2016610053", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-06-04", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-07-01" + }, + { + "c3Code": "C3-2026-000222", + "model": "IS-7.0", + "batchNo": "H2630577", + "registrationNo": "国械注进2020811293", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2024-07-06", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2024-07-17" + }, + { + "c3Code": "C3-2026-000223", + "model": "AV-SET-A", + "batchNo": 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"productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2024-08-16", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-09-20" + }, + { + "c3Code": "C3-2026-000263", + "model": "HD-180", + "batchNo": "F2970090", + "registrationNo": "国械注进2016575376", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2024-03-13", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-04-01" + }, + { + "c3Code": "C3-2026-000264", + "model": "1.3m²", + "batchNo": "E2645593", + "registrationNo": "国械注进2015106362", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2024-06-15", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-07-11" + }, + { + "c3Code": "C3-2026-000265", + "model": "1.3m²", + "batchNo": "C2680249", + "registrationNo": "国械注进2022888019", + "productName": 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"registerDate": "2024-10-26", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-12-27" + }, + { + "c3Code": "C3-2026-000287", + "model": "AV-SET-P", + "batchNo": "F9841474", + "registrationNo": "国械注进2021991395", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2024-11-18", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-12-24" + }, + { + "c3Code": "C3-2026-000288", + "model": "IS-5.0", + "batchNo": "C9820531", + "registrationNo": "国械注进2018481641", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "堵塞", + "registerDate": "2024-10-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-10-11" + }, + { + "c3Code": "C3-2026-000289", + "model": "22G", + "batchNo": "D7566654", + "registrationNo": "国械注进2017842302", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-11-28", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-01-19" + }, + { + "c3Code": "C3-2026-000290", + "model": "1.3m²", + "batchNo": "A1609834", + "registrationNo": "国械注进2024334631", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-04-21", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-04-26" + }, + { + "c3Code": "C3-2026-000291", + "model": "IS-7.0", + "batchNo": "F3500618", + "registrationNo": "国械注进2018628386", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "标签不清", + "registerDate": "2024-03-23", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2024-04-18" + }, + { + "c3Code": "C3-2026-000292", + "model": "1.4m²", + "batchNo": "B4531071", + "registrationNo": "国械注进2022692431", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2025-01-14", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-02-07" + }, + { + "c3Code": "C3-2026-000293", + "model": "IS-5.0", + "batchNo": "B9070655", + "registrationNo": "国械注进2024950748", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2024-12-25", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-12-25" + }, + { + "c3Code": "C3-2026-000294", + "model": "5-0", + "batchNo": "F6761067", + "registrationNo": "国械注进2017560131", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "标签不清", + "registerDate": "2024-12-21", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-01-24" + }, + { + "c3Code": "C3-2026-000295", + "model": "AV-SET-P", + "batchNo": "D8868411", + "registrationNo": "国械注进2025142289", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2024-03-22", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-05-12" + }, + { + "c3Code": "C3-2026-000296", + "model": "Introcan Safety 20G", + "batchNo": "E1035690", + "registrationNo": "国械注进2023252220", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2025-10-25", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-11-29" + }, + { + "c3Code": "C3-2026-000297", + "model": "Introcan Safety 20G", + "batchNo": "A4317954", + "registrationNo": "国械注进2026435237", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2024-11-01", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-11-28" + }, + { + "c3Code": "C3-2026-000298", + "model": "22G", + "batchNo": "A5170335", + "registrationNo": "国械注进2018103950", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2023-08-28", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2023-10-11" + }, + { + "c3Code": "C3-2026-000299", + "model": "22G", + "batchNo": "E9740692", + "registrationNo": "国械注进2018727458", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2025-06-06", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-07-10" + }, + { + "c3Code": "C3-2026-000300", + "model": "HD-180", + "batchNo": "H3191072", + "registrationNo": "国械注进2018919334", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-03-19", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-04-11" + }, + { + "c3Code": "C3-2026-000301", + "model": "IS-7.0", + "batchNo": "E3408091", + "registrationNo": "国械注进2021188233", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2026-02-19", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2026-03-18" + }, + { + "c3Code": "C3-2026-000302", + "model": "IS-5.0", + "batchNo": "A9770123", + "registrationNo": "国械注进2018714081", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2023-11-01", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2023-12-12" + }, + { + "c3Code": "C3-2026-000303", + "model": "3-0", + "batchNo": "E1953814", + "registrationNo": "国械注进2015700779", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2025-12-01", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-12-01" + }, + { + "c3Code": "C3-2026-000304", + "model": "5-0", + "batchNo": "B4722171", + "registrationNo": "国械注进2022915261", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-08-14", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-09-19" + }, + { + "c3Code": "C3-2026-000305", + "model": "5-0", + "batchNo": "G2808598", + "registrationNo": "国械注进2019497019", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2024-12-06", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-01-19" + }, + { + "c3Code": "C3-2026-000306", + "model": "AV-SET-A", + "batchNo": "H7442165", + "registrationNo": "国械注进2018953146", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-10-03", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-12-07" + }, + { + "c3Code": "C3-2026-000307", + "model": "22G", + "batchNo": "C3147033", + "registrationNo": "国械注进2023101184", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2026-03-10", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-04-05" + }, + { + "c3Code": "C3-2026-000308", + "model": "24G", + "batchNo": "D7598644", + "registrationNo": "国械注进2026533824", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2025-10-25", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-11-28" + }, + { + "c3Code": "C3-2026-000309", + "model": "HD-180", + "batchNo": "C6383435", + "registrationNo": "国械注进2015199890", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2024-04-19", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2024-05-22" + }, + { + "c3Code": "C3-2026-000310", + "model": "AV-SET-P", + "batchNo": "D8224407", + "registrationNo": "国械注进2022665938", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2024-10-27", + "isAe": true, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2024-11-05" + }, + { + "c3Code": "C3-2026-000311", + "model": "PF-5.0", + "batchNo": "C7183698", + "registrationNo": "国械注进2020707553", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2025-09-26", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-10-21" + }, + { + "c3Code": "C3-2026-000312", + "model": "PF-5.0", + "batchNo": "A2672484", + "registrationNo": "国械注进2017466925", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "堵塞", + "registerDate": "2025-02-28", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-02-28" + }, + { + "c3Code": "C3-2026-000313", + "model": "1.3m²", + "batchNo": "E4704829", + "registrationNo": "国械注进2020360651", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "断裂", + "registerDate": "2025-04-27", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-06-29" + }, + { + "c3Code": "C3-2026-000314", + "model": "IS-5.0", + "batchNo": "A7838168", + "registrationNo": "国械注进2025200333", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2024-02-06", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-02-06" + }, + { + "c3Code": "C3-2026-000315", + "model": "HD-180", + "batchNo": "H5057652", + "registrationNo": "国械注进2025192091", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-06-17", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-07-30" + }, + { + "c3Code": "C3-2026-000316", + "model": "3-0", + "batchNo": "A7544419", + "registrationNo": "国械注进2015296071", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2024-09-20", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-10-19" + }, + { + "c3Code": "C3-2026-000317", + "model": "IS-7.0", + "batchNo": "F8645340", + "registrationNo": "国械注进2023592063", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2025-05-08", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-06-09" + }, + { + "c3Code": "C3-2026-000318", + "model": "4-0", + "batchNo": "F5094448", + "registrationNo": "国械注进2019735568", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2025-06-06", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-06-06" + }, + { + "c3Code": "C3-2026-000319", + "model": "5-0", + "batchNo": "G2000722", + "registrationNo": "国械注进2018369760", + "productName": "可吸收性外科缝线", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2024-06-30", + "isAe": false, + "conclusion": 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"compensation": "其他协商处理", + "closeDate": "2026-03-26" + }, + { + "c3Code": "C3-2026-000323", + "model": "1.3m²", + "batchNo": "F3871818", + "registrationNo": "国械注进2016372685", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2026-03-27", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2026-03-27" + }, + { + "c3Code": "C3-2026-000324", + "model": "1.4m²", + "batchNo": "A1579806", + "registrationNo": "国械注进2021482465", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2024-12-13", + "isAe": true, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-12-25" + }, + { + "c3Code": "C3-2026-000325", + "model": "AV-SET-A", + "batchNo": "B1318201", + "registrationNo": "国械注进2024168674", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2024-04-13", + "isAe": true, + "conclusion": "未复现", + "compensation": 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"closeDate": "2024-03-24" + }, + { + "c3Code": "C3-2026-000329", + "model": "AV-SET-A", + "batchNo": "H8265919", + "registrationNo": "国械注进2017874864", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2025-09-08", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-09-30" + }, + { + "c3Code": "C3-2026-000330", + "model": "Introcan Safety 20G", + "batchNo": "B9918038", + "registrationNo": "国械注进2016601717", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2023-12-20", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-29" + }, + { + "c3Code": "C3-2026-000331", + "model": "AV-SET-A", + "batchNo": "D8072117", + "registrationNo": "国械注进2025541887", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2024-11-07", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", 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"c3Code": "C3-2026-000371", + "model": "20G", + "batchNo": "H8510688", + "registrationNo": "国械注进2023670417", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2026-02-05", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2026-03-21" + }, + { + "c3Code": "C3-2026-000372", + "model": "IS-7.0", + "batchNo": "B8056865", + "registrationNo": "国械注进2018805446", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2025-11-16", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-12-20" + }, + { + "c3Code": "C3-2026-000373", + "model": "IS-7.0", + "batchNo": "E7152064", + "registrationNo": "国械注进2020921637", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "堵塞", + "registerDate": "2025-03-08", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-05-05" + }, + { + "c3Code": 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}, + { + "c3Code": "C3-2026-000404", + "model": "HD-180", + "batchNo": "F2946464", + "registrationNo": "国械注进2023863972", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2024-11-06", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-12-17" + }, + { + "c3Code": "C3-2026-000405", + "model": "1.3m²", + "batchNo": "E4168209", + "registrationNo": "国械注进2022788437", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2023-12-12", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-16" + }, + { + "c3Code": "C3-2026-000406", + "model": "PF-5.0", + "batchNo": "G9125265", + "registrationNo": "国械注进2020484540", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2023-10-23", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-11-17" + }, + { + "c3Code": 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+ "faultType": "包装破损", + "registerDate": "2023-11-16", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2023-12-27" + }, + { + "c3Code": "C3-2026-000483", + "model": "5-0", + "batchNo": "H1176574", + "registrationNo": "国械注进2022660286", + "productName": "可吸收性外科缝线", + "hospitalName": "上海市第一人民医院", + "faultType": "断裂", + "registerDate": "2025-01-02", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-03-02" + }, + { + "c3Code": "C3-2026-000484", + "model": "PF-5.0", + "batchNo": "A5336275", + "registrationNo": "国械注进2022562218", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2025-08-18", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-10-06" + }, + { + "c3Code": "C3-2026-000485", + "model": "AV-SET-A", + "batchNo": "B9698869", + "registrationNo": "国械注进2024252075", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2023-09-22", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-09-22" + }, + { + "c3Code": "C3-2026-000486", + "model": "AV-SET-A", + "batchNo": "H1801696", + "registrationNo": "国械注进2025598322", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "连接不牢", + "registerDate": "2025-07-21", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-08-27" + }, + { + "c3Code": "C3-2026-000487", + "model": "3-0", + "batchNo": "D3301886", + "registrationNo": "国械注进2017112365", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2024-01-25", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-02-11" + }, + { + "c3Code": "C3-2026-000488", + "model": "PF-5.0", + "batchNo": "C8705751", + "registrationNo": "国械注进2015983019", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-12-29", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2025-12-29" + }, + { + "c3Code": "C3-2026-000489", + "model": "IS-7.0", + "batchNo": "F6998633", + "registrationNo": "国械注进2026164184", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2026-04-09", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-05-13" + }, + { + "c3Code": "C3-2026-000490", + "model": "IS-7.0", + "batchNo": "B3067723", + "registrationNo": "国械注进2018734000", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "流速异常", + "registerDate": "2023-11-08", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2023-12-18" + }, + { + "c3Code": "C3-2026-000491", + "model": "HD-180", + "batchNo": "A2282209", + "registrationNo": "国械注进2024875617", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2025-07-14", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-07-14" + }, + { + "c3Code": "C3-2026-000492", + "model": "4-0", + "batchNo": "A9412183", + "registrationNo": "国械注进2015263092", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2023-09-21", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2023-09-21" + }, + { + "c3Code": "C3-2026-000493", + "model": "4-0", + "batchNo": "A5950124", + "registrationNo": "国械注进2022285162", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2024-01-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-02-29" + }, + { + "c3Code": "C3-2026-000494", + "model": "4-0", + "batchNo": "H2471938", + "registrationNo": "国械注进2025851166", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2025-12-03", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-12-19" + }, + { + "c3Code": "C3-2026-000495", + "model": "3-0", + "batchNo": "B5466107", + "registrationNo": "国械注进2020107039", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "断裂", + "registerDate": "2023-10-26", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2023-12-10" + }, + { + "c3Code": "C3-2026-000496", + "model": "1.4m²", + "batchNo": "F9958186", + "registrationNo": "国械注进2016404298", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2024-10-12", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-11-10" + }, + { + "c3Code": "C3-2026-000497", + "model": "22G", + "batchNo": "E7030165", + "registrationNo": "国械注进2022645690", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-03-25", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-04-11" + }, + { + "c3Code": "C3-2026-000498", + "model": "IS-5.0", + "batchNo": "B7223012", + "registrationNo": "国械注进2018120976", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2025-10-29", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-12-16" + }, + { + "c3Code": "C3-2026-000499", + "model": "IS-5.0", + "batchNo": "A6915780", + "registrationNo": "国械注进2016631127", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-10-04", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-11-12" + }, + { + "c3Code": "C3-2026-000500", + "model": "AV-SET-P", + "batchNo": "A4351396", + "registrationNo": "国械注进2019906947", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2026-02-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-03-24" + }, + { + "c3Code": "C3-2026-000501", + "model": "PF-5.0", + "batchNo": "H5071566", + "registrationNo": "国械注进2019483543", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2024-04-05", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-04-05" + }, + { + "c3Code": "C3-2026-000502", + "model": "IS-7.0", + "batchNo": "G7291218", + "registrationNo": "国械注进2025869808", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "渗漏", + "registerDate": "2023-10-29", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-11-12" + }, + { + "c3Code": "C3-2026-000503", + "model": "PF-5.0", + "batchNo": "H2402087", + "registrationNo": "国械注进2016875970", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2024-12-05", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-12-05" + }, + { + "c3Code": "C3-2026-000504", + "model": "5-0", + "batchNo": "G8068000", + "registrationNo": "国械注进2015803723", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2026-02-03", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2026-02-09" + }, + { + "c3Code": "C3-2026-000505", + "model": "Introcan Safety 20G", + "batchNo": "F8441802", + "registrationNo": "国械注进2016353395", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-08-24", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-09-11" + }, + { + "c3Code": "C3-2026-000506", + "model": "AV-SET-A", + "batchNo": "D4601033", + "registrationNo": "国械注进2015788036", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + 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"faultType": "连接不牢", + "registerDate": "2024-07-29", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-08-01" + }, + { + "c3Code": "C3-2026-000510", + "model": "Introcan Safety 20G", + "batchNo": "D2528461", + "registrationNo": "国械注进2018401469", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-09-12", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-11-10" + }, + { + "c3Code": "C3-2026-000511", + "model": "1.3m²", + "batchNo": "E2285266", + "registrationNo": "国械注进2020584523", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2025-03-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-29" + }, + { + "c3Code": "C3-2026-000512", + "model": "PF-5.0", + "batchNo": "E4907220", + "registrationNo": "国械注进2020905393", + "productName": "一次性使用输液器", + "hospitalName": 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"faultType": "流速异常", + "registerDate": "2024-05-26", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-06-27" + }, + { + "c3Code": "C3-2026-000516", + "model": "HD-180", + "batchNo": "C2507139", + "registrationNo": "国械注进2026221839", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2026-01-06", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2026-01-06" + }, + { + "c3Code": "C3-2026-000517", + "model": "AV-SET-P", + "batchNo": "H4192276", + "registrationNo": "国械注进2026356742", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2025-04-06", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-06-04" + }, + { + "c3Code": "C3-2026-000518", + "model": "AV-SET-P", + "batchNo": "A4968294", + "registrationNo": "国械注进2015174646", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-09-27", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-11-01" + }, + { + "c3Code": "C3-2026-000519", + "model": "1.4m²", + "batchNo": "B6674708", + "registrationNo": "国械注进2015909754", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2025-10-06", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-10-10" + }, + { + "c3Code": "C3-2026-000520", + "model": "PF-5.0", + "batchNo": "F8838553", + "registrationNo": "国械注进2018874711", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2024-04-04", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-05-04" + }, + { + "c3Code": "C3-2026-000521", + "model": "HD-180", + "batchNo": "D5045694", + "registrationNo": "国械注进2016341540", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2024-07-18", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-08-28" + }, + { + "c3Code": "C3-2026-000522", + "model": "5-0", + "batchNo": "H2927027", + "registrationNo": "国械注进2025282901", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2024-12-05", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-01-02" + }, + { + "c3Code": "C3-2026-000523", + "model": "4-0", + "batchNo": "G6851536", + "registrationNo": "国械注进2021410091", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-01-12", + "isAe": true, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2024-02-12" + }, + { + "c3Code": "C3-2026-000524", + "model": "22G", + "batchNo": "B8050438", + "registrationNo": "国械注进2018460292", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2025-04-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-04-04" + }, + { + "c3Code": "C3-2026-000525", + "model": "4-0", + "batchNo": "E7421065", + "registrationNo": "国械注进2019950051", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2024-02-24", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-03-01" + }, + { + "c3Code": "C3-2026-000526", + "model": "HD-180", + "batchNo": "H6126495", + "registrationNo": "国械注进2018329110", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "断裂", + "registerDate": "2024-06-15", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2024-07-24" + }, + { + "c3Code": "C3-2026-000527", + "model": "24G", + "batchNo": "D3307806", + "registrationNo": "国械注进2015916426", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2024-06-24", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-07-04" + }, + { + "c3Code": "C3-2026-000528", + "model": "AV-SET-A", + "batchNo": "F5721936", + "registrationNo": "国械注进2015564065", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2023-10-15", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-12-03" + }, + { + "c3Code": "C3-2026-000529", + "model": "Introcan Safety 20G", + "batchNo": "F4444206", + "registrationNo": "国械注进2022459725", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2025-11-17", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2026-01-15" + }, + { + "c3Code": "C3-2026-000530", + "model": "1.4m²", + "batchNo": "G8394932", + "registrationNo": "国械注进2015279551", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2025-12-10", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2026-02-06" + }, + { + "c3Code": "C3-2026-000531", + "model": "4-0", + "batchNo": "D1061439", + "registrationNo": "国械注进2022195307", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2024-12-03", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-12-22" + }, + { + "c3Code": "C3-2026-000532", + "model": "20G", + "batchNo": "E6939439", + "registrationNo": "国械注进2016569145", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2025-02-10", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-02-26" + }, + { + "c3Code": "C3-2026-000533", + "model": "Introcan Safety 20G", + "batchNo": "C3325913", + "registrationNo": "国械注进2025667423", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2023-10-14", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2023-11-15" + }, + { + "c3Code": "C3-2026-000534", + "model": "AV-SET-P", + "batchNo": "C7561156", + "registrationNo": "国械注进2021909321", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-04-16", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-05-12" + }, + { + "c3Code": "C3-2026-000535", + "model": "1.4m²", + "batchNo": "H5951773", + "registrationNo": "国械注进2022761535", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-09-20", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-10-19" + }, + { + "c3Code": "C3-2026-000536", + "model": "Introcan Safety 20G", + "batchNo": "B1205597", + "registrationNo": "国械注进2015590465", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2025-09-23", + "isAe": true, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-09-23" + }, + { + "c3Code": "C3-2026-000537", + "model": "IS-7.0", + "batchNo": "H6175445", + "registrationNo": "国械注进2022926886", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "堵塞", + "registerDate": "2024-08-26", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-10-26" + }, + { + "c3Code": "C3-2026-000538", + "model": "3-0", + "batchNo": "E9003414", + "registrationNo": "国械注进2020933737", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-08-12", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-10-02" + }, + { + "c3Code": "C3-2026-000539", + "model": "4-0", + "batchNo": "G4539292", + "registrationNo": "国械注进2018576561", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2024-08-09", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-09-17" + }, + { + "c3Code": "C3-2026-000540", + "model": "AV-SET-A", + "batchNo": "D1190848", + "registrationNo": "国械注进2022303339", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2024-06-23", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-09-01" + }, + { + "c3Code": "C3-2026-000541", + "model": "PF-5.0", + "batchNo": "C5778963", + "registrationNo": "国械注进2018269415", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-11-08", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-12-05" + }, + { + "c3Code": "C3-2026-000542", + "model": "24G", + "batchNo": "F1311589", + "registrationNo": "国械注进2018433040", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2025-10-16", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-11-30" + }, + { + "c3Code": "C3-2026-000543", + "model": "20G", + "batchNo": "H9757538", + "registrationNo": "国械注进2016642692", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2023-10-19", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2023-11-25" + }, + { + "c3Code": "C3-2026-000544", + "model": "3-0", + "batchNo": "G4924606", + "registrationNo": "国械注进2015401447", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2023-08-10", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-10-17" + }, + { + "c3Code": "C3-2026-000545", + "model": "IS-5.0", + "batchNo": "A6223665", + "registrationNo": "国械注进2023992124", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2024-04-20", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2024-06-07" + }, + { + "c3Code": "C3-2026-000546", + "model": "1.3m²", + "batchNo": "F4742575", + "registrationNo": "国械注进2020248524", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2024-05-10", + "isAe": true, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2024-05-10" + }, + { + "c3Code": "C3-2026-000547", + "model": "5-0", + "batchNo": "G8682063", + "registrationNo": "国械注进2021791778", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2024-12-03", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2024-12-03" + }, + { + "c3Code": "C3-2026-000548", + "model": "IS-7.0", + "batchNo": "A5824583", + "registrationNo": "国械注进2023759176", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2025-05-25", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-07-13" + }, + { + "c3Code": "C3-2026-000549", + "model": "3-0", + "batchNo": "E2020980", + "registrationNo": "国械注进2024378130", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "标签不清", + "registerDate": "2023-10-02", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-10-02" + }, + { + "c3Code": "C3-2026-000550", + "model": "IS-7.0", + "batchNo": "H9825227", + "registrationNo": "国械注进2018370980", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2023-11-20", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-01-09" + }, + { + "c3Code": "C3-2026-000551", + "model": "Introcan Safety 20G", + "batchNo": "B3969353", + "registrationNo": "国械注进2025725151", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2025-12-13", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-12-13" + }, + { + "c3Code": "C3-2026-000552", + "model": "5-0", + "batchNo": "B6768661", + "registrationNo": "国械注进2024155553", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "标签不清", + "registerDate": "2025-07-12", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-08-06" + }, + { + "c3Code": "C3-2026-000553", + "model": "4-0", + "batchNo": "A9903213", + "registrationNo": "国械注进2019154749", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2026-03-08", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-03-20" + }, + { + "c3Code": "C3-2026-000554", + "model": "IS-7.0", + "batchNo": "D7222214", + "registrationNo": "国械注进2024857799", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2024-06-02", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-06-09" + }, + { + "c3Code": "C3-2026-000555", + "model": "1.4m²", + "batchNo": "A8425043", + "registrationNo": "国械注进2022349922", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2024-01-25", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-03-16" + }, + { + "c3Code": "C3-2026-000556", + "model": "4-0", + "batchNo": "C1693785", + "registrationNo": "国械注进2019866235", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2024-09-06", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-10-13" + }, + { + "c3Code": "C3-2026-000557", + "model": "Introcan Safety 20G", + "batchNo": "D1972790", + "registrationNo": "国械注进2017872667", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2026-01-14", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2026-02-04" + }, + { + "c3Code": "C3-2026-000558", + "model": "3-0", + "batchNo": "B4102473", + "registrationNo": "国械注进2019386320", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2025-08-05", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2025-08-05" + }, + { + "c3Code": "C3-2026-000559", + "model": "AV-SET-P", + "batchNo": "B5949199", + "registrationNo": "国械注进2015372121", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-10-07", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-10-23" + }, + { + "c3Code": "C3-2026-000560", + "model": "5-0", + "batchNo": "C7349228", + "registrationNo": "国械注进2017155187", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "断裂", + "registerDate": "2023-11-17", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2023-12-17" + }, + { + "c3Code": "C3-2026-000561", + "model": "HD-180", + "batchNo": "C3280071", + "registrationNo": "国械注进2022718218", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "流速异常", + "registerDate": "2023-12-02", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-08" + }, + { + "c3Code": "C3-2026-000562", + "model": "AV-SET-P", + "batchNo": "A6969277", + "registrationNo": "国械注进2020231438", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-07-23", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-09-16" + }, + { + "c3Code": "C3-2026-000563", + "model": "4-0", + "batchNo": "D3967364", + "registrationNo": "国械注进2019473315", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-08-03", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-08-07" + }, + { + "c3Code": "C3-2026-000564", + "model": "AV-SET-A", + "batchNo": "E2591294", + "registrationNo": "国械注进2025544989", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "堵塞", + "registerDate": "2026-01-04", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-02-25" + }, + { + "c3Code": "C3-2026-000565", + "model": "IS-5.0", + "batchNo": "C3472102", + "registrationNo": "国械注进2015276412", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-02-13", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-04-07" + }, + { + "c3Code": "C3-2026-000566", + "model": "1.3m²", + "batchNo": "E3408287", + "registrationNo": "国械注进2019380838", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2025-11-11", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2025-11-11" + }, + { + "c3Code": "C3-2026-000567", + "model": "Introcan Safety 20G", + "batchNo": "D1872033", + "registrationNo": "国械注进2019124256", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2025-11-24", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-12-30" + }, + { + "c3Code": "C3-2026-000568", + "model": "22G", + "batchNo": "B2701557", + "registrationNo": "国械注进2021887701", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2025-12-28", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-02-13" + }, + { + "c3Code": "C3-2026-000569", + "model": "IS-5.0", + "batchNo": "A4229357", + "registrationNo": "国械注进2020537308", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2025-12-20", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-12-20" + }, + { + "c3Code": "C3-2026-000570", + "model": "22G", + "batchNo": "A2428720", + "registrationNo": "国械注进2020470141", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2026-03-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-05-06" + }, + { + "c3Code": "C3-2026-000571", + "model": "3-0", + "batchNo": "F7387002", + "registrationNo": "国械注进2025644628", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2024-06-13", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-08-22" + }, + { + "c3Code": "C3-2026-000572", + "model": "AV-SET-A", + "batchNo": "C1183573", + "registrationNo": "国械注进2015602447", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2023-09-10", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2023-10-28" + }, + { + "c3Code": "C3-2026-000573", + "model": "AV-SET-A", + "batchNo": "F5907137", + "registrationNo": "国械注进2019511730", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2026-02-16", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-04-01" + }, + { + "c3Code": "C3-2026-000574", + "model": "Introcan Safety 20G", + "batchNo": "H7638345", + "registrationNo": "国械注进2015697972", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2024-07-16", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-09-14" + }, + { + "c3Code": "C3-2026-000575", + "model": "PF-5.0", + "batchNo": "G5556968", + "registrationNo": "国械注进2023736831", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2024-11-22", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-12-24" + }, + { + "c3Code": "C3-2026-000576", + "model": "4-0", + "batchNo": "C4734652", + "registrationNo": "国械注进2026858162", + "productName": "可吸收性外科缝线", + "hospitalName": "上海市第一人民医院", + "faultType": "标签不清", + "registerDate": "2026-02-09", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2026-04-11" + }, + { + "c3Code": "C3-2026-000577", + "model": "22G", + "batchNo": "B8526036", + "registrationNo": "国械注进2026608595", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2025-10-16", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-10-30" + }, + { + "c3Code": "C3-2026-000578", + "model": "5-0", + "batchNo": "A1989984", + "registrationNo": "国械注进2022642164", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2025-09-07", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-10-01" + }, + { + "c3Code": "C3-2026-000579", + "model": "AV-SET-A", + "batchNo": "G4558633", + "registrationNo": "国械注进2026321136", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-04-10", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-05-21" + }, + { + "c3Code": "C3-2026-000580", + "model": "IS-5.0", + "batchNo": "E2150587", + "registrationNo": "国械注进2022786999", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2024-08-22", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-09-03" + }, + { + "c3Code": "C3-2026-000581", + "model": "Introcan Safety 20G", + "batchNo": "B8913218", + "registrationNo": "国械注进2021373480", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2026-03-27", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2026-04-03" + }, + { + "c3Code": "C3-2026-000582", + "model": "5-0", + "batchNo": "G8485584", + "registrationNo": "国械注进2026909137", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2025-02-08", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-03-22" + }, + { + "c3Code": "C3-2026-000583", + "model": "IS-5.0", + "batchNo": "E6956759", + "registrationNo": "国械注进2018722485", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "堵塞", + "registerDate": "2026-03-18", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2026-03-21" + }, + { + "c3Code": "C3-2026-000584", + "model": "AV-SET-P", + "batchNo": "C7585033", + "registrationNo": "国械注进2018706557", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-09-17", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-09-30" + }, + { + "c3Code": "C3-2026-000585", + "model": "4-0", + "batchNo": "B3940201", + "registrationNo": "国械注进2020164565", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "断裂", + "registerDate": "2023-09-07", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-09-07" + }, + { + "c3Code": "C3-2026-000586", + "model": "24G", + "batchNo": "H1589019", + "registrationNo": "国械注进2020668383", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2025-04-21", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-06-26" + }, + { + "c3Code": "C3-2026-000587", + "model": "1.4m²", + "batchNo": "B6022779", + "registrationNo": "国械注进2020351348", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2026-03-28", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-05-20" + }, + { + "c3Code": "C3-2026-000588", + "model": "1.4m²", + "batchNo": "F5060865", + "registrationNo": "国械注进2015864941", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2023-12-27", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-01-26" + }, + { + "c3Code": "C3-2026-000589", + "model": "IS-5.0", + "batchNo": "A8045968", + "registrationNo": "国械注进2024808105", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "堵塞", + "registerDate": "2023-10-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-11-04" + }, + { + "c3Code": "C3-2026-000590", + "model": "22G", + "batchNo": "G6914275", + "registrationNo": "国械注进2025192394", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2025-01-09", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-01-09" + }, + { + "c3Code": "C3-2026-000591", + "model": "3-0", + "batchNo": "H8607026", + "registrationNo": "国械注进2026821511", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2024-09-20", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-11-04" + }, + { + "c3Code": "C3-2026-000592", + "model": "20G", + "batchNo": "G3468056", + "registrationNo": "国械注进2017772052", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2025-07-15", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-07-15" + }, + { + "c3Code": "C3-2026-000593", + "model": "AV-SET-P", + "batchNo": "F2789485", + "registrationNo": "国械注进2025710152", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2026-02-23", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-03-11" + }, + { + "c3Code": "C3-2026-000594", + "model": "HD-180", + "batchNo": "C8658487", + "registrationNo": "国械注进2025668572", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2024-04-07", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-04-23" + }, + { + "c3Code": "C3-2026-000595", + "model": "HD-180", + "batchNo": "F3130482", + "registrationNo": "国械注进2019432653", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2023-08-20", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2023-09-03" + }, + { + "c3Code": "C3-2026-000596", + "model": "AV-SET-A", + "batchNo": "A7005284", + "registrationNo": "国械注进2017129015", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2026-02-09", + "isAe": true, + "conclusion": "操作不当", + "compensation": 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"closeDate": "2026-03-10" + }, + { + "c3Code": "C3-2026-000600", + "model": "AV-SET-A", + "batchNo": "E1034992", + "registrationNo": "国械注进2022515026", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2023-12-19", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-02-01" + }, + { + "c3Code": "C3-2026-000601", + "model": "20G", + "batchNo": "G8038421", + "registrationNo": "国械注进2015418833", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "流速异常", + "registerDate": "2024-11-20", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-01-04" + }, + { + "c3Code": "C3-2026-000602", + "model": "IS-5.0", + "batchNo": "B3373671", + "registrationNo": "国械注进2017178897", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2025-06-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-06-29" + }, + { + "c3Code": "C3-2026-000603", + "model": "IS-7.0", + "batchNo": "F9120249", + "registrationNo": "国械注进2015812411", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "标签不清", + "registerDate": "2024-10-27", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-12-02" + }, + { + "c3Code": "C3-2026-000604", + "model": "AV-SET-A", + "batchNo": "C8810489", + "registrationNo": "国械注进2023440140", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-10-15", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-11-27" + }, + { + "c3Code": "C3-2026-000605", + "model": "AV-SET-A", + "batchNo": "A3407896", + "registrationNo": "国械注进2021262299", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2023-08-24", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": 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"2025-09-24" + }, + { + "c3Code": "C3-2026-000609", + "model": "AV-SET-P", + "batchNo": "B3117564", + "registrationNo": "国械注进2015866093", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2026-03-11", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2026-04-10" + }, + { + "c3Code": "C3-2026-000610", + "model": "HD-180", + "batchNo": "F8896230", + "registrationNo": "国械注进2026616127", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2025-11-20", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-12-26" + }, + { + "c3Code": "C3-2026-000611", + "model": "Introcan Safety 20G", + "batchNo": "C9354093", + "registrationNo": "国械注进2016922125", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2024-03-03", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-03-10" + }, + { + "c3Code": "C3-2026-000612", + "model": "4-0", + "batchNo": "C5468830", + "registrationNo": "国械注进2017705974", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "包装破损", + "registerDate": "2025-11-02", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-11-02" + }, + { + "c3Code": "C3-2026-000613", + "model": "1.4m²", + "batchNo": "A7168445", + "registrationNo": "国械注进2016654072", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2024-02-24", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2024-03-19" + }, + { + "c3Code": "C3-2026-000614", + "model": "AV-SET-A", + "batchNo": "E5491687", + "registrationNo": "国械注进2016472288", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2025-09-08", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-10-17" + }, + { + "c3Code": "C3-2026-000615", + "model": "AV-SET-A", + "batchNo": "G8257831", + "registrationNo": "国械注进2016697920", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "堵塞", + "registerDate": "2026-04-07", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2026-05-08" + }, + { + "c3Code": "C3-2026-000616", + "model": "1.3m²", + "batchNo": "B1539580", + "registrationNo": "国械注进2025975382", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2025-03-21", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-03-21" + }, + { + "c3Code": "C3-2026-000617", + "model": "IS-7.0", + "batchNo": "A9946133", + "registrationNo": "国械注进2021279742", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2024-05-31", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-07-03" + }, + { 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"model": "AV-SET-A", + "batchNo": "C9697722", + "registrationNo": "国械注进2016162568", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2025-04-25", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-05-11" + }, + { + "c3Code": "C3-2026-000631", + "model": "IS-5.0", + "batchNo": "A5195842", + "registrationNo": "国械注进2025945882", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2026-04-04", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-04-23" + }, + { + "c3Code": "C3-2026-000632", + "model": "PF-5.0", + "batchNo": "F7575684", + "registrationNo": "国械注进2015416071", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2024-05-25", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-06-06" + }, + { + "c3Code": "C3-2026-000633", + "model": "AV-SET-P", + "batchNo": "A4218654", + "registrationNo": "国械注进2025770800", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "连接不牢", + "registerDate": "2024-01-19", + "isAe": true, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2024-01-19" + }, + { + "c3Code": "C3-2026-000634", + "model": "IS-7.0", + "batchNo": "H9667756", + "registrationNo": "国械注进2018139767", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "堵塞", + "registerDate": "2024-12-12", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-12-20" + }, + { + "c3Code": "C3-2026-000635", + "model": "AV-SET-A", + "batchNo": "D8516872", + "registrationNo": "国械注进2017268086", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2024-02-23", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2024-04-25" + }, + { + "c3Code": "C3-2026-000636", + "model": 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"batchNo": "A8993536", + "registrationNo": "国械注进2022534973", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2024-09-10", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-09-13" + }, + { + "c3Code": "C3-2026-000640", + "model": "AV-SET-P", + "batchNo": "F2207146", + "registrationNo": "国械注进2020267108", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2023-12-11", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-01-08" + }, + { + "c3Code": "C3-2026-000641", + "model": "22G", + "batchNo": "D8295070", + "registrationNo": "国械注进2015142412", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-02-09", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-12" + }, + { + "c3Code": "C3-2026-000642", + "model": "24G", + "batchNo": 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"A3980881", + "registrationNo": "国械注进2019451312", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2024-01-21", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-02-23" + }, + { + "c3Code": "C3-2026-000646", + "model": "5-0", + "batchNo": "G6805967", + "registrationNo": "国械注进2018933533", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2025-02-06", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-03-19" + }, + { + "c3Code": "C3-2026-000647", + "model": "Introcan Safety 20G", + "batchNo": "C7583102", + "registrationNo": "国械注进2017685481", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2025-03-15", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-03-30" + }, + { + "c3Code": "C3-2026-000648", + "model": "3-0", + "batchNo": "B4994214", + "registrationNo": "国械注进2018215552", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-03-06", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-04-06" + }, + { + "c3Code": "C3-2026-000649", + "model": "1.3m²", + "batchNo": "B8550121", + "registrationNo": "国械注进2024267234", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2024-06-13", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-06-16" + }, + { + "c3Code": "C3-2026-000650", + "model": "1.3m²", + "batchNo": "C9571456", + "registrationNo": "国械注进2015336206", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-12-13", + "isAe": true, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2025-01-29" + }, + { + "c3Code": "C3-2026-000651", + "model": "HD-180", + "batchNo": "H5065254", + "registrationNo": "国械注进2019712641", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "包装破损", + "registerDate": "2024-05-24", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-06-02" + }, + { + "c3Code": "C3-2026-000652", + "model": "IS-5.0", + "batchNo": "D2274202", + "registrationNo": "国械注进2016555600", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-01-11", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-02-26" + }, + { + "c3Code": "C3-2026-000653", + "model": "4-0", + "batchNo": "C3415160", + "registrationNo": "国械注进2020753642", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2025-07-26", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-08-22" + }, + { + "c3Code": "C3-2026-000654", + "model": "HD-180", + "batchNo": "H8118399", + "registrationNo": "国械注进2022233525", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2023-09-08", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-10-14" + }, + { + "c3Code": "C3-2026-000655", + "model": "Introcan Safety 20G", + "batchNo": "H1062283", + "registrationNo": "国械注进2018422748", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2025-09-30", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-11-12" + }, + { + "c3Code": "C3-2026-000656", + "model": "22G", + "batchNo": "H6235747", + "registrationNo": "国械注进2015225038", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2026-01-10", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-01-13" + }, + { + "c3Code": "C3-2026-000657", + "model": "IS-7.0", + "batchNo": "F7111828", + "registrationNo": "国械注进2015395621", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2025-10-24", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-11-11" + }, + { + "c3Code": "C3-2026-000658", + "model": "1.4m²", + "batchNo": "G4238908", + "registrationNo": "国械注进2020225644", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2025-12-09", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-01-16" + }, + { + "c3Code": "C3-2026-000659", + "model": "22G", + "batchNo": "E7419953", + "registrationNo": "国械注进2015686710", + "productName": "一次性使用静脉留置针", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2025-06-19", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-08-15" + }, + { + "c3Code": "C3-2026-000660", + "model": "IS-7.0", + "batchNo": 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"registrationNo": "国械注进2026577282", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2024-03-09", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-04-03" + }, + { + "c3Code": "C3-2026-000667", + "model": "3-0", + "batchNo": "C6262413", + "registrationNo": "国械注进2024191982", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2025-01-08", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-02-18" + }, + { + "c3Code": "C3-2026-000668", + "model": "AV-SET-A", + "batchNo": "D2858100", + "registrationNo": "国械注进2026174385", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2024-05-30", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-06-19" + }, + { + "c3Code": "C3-2026-000669", + "model": "5-0", + "batchNo": "B6919810", + "registrationNo": "国械注进2020392430", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-03-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-03-29" + }, + { + "c3Code": "C3-2026-000670", + "model": "Introcan Safety 20G", + "batchNo": "G8220711", + "registrationNo": "国械注进2025618930", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-01-17", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-02-21" + }, + { + "c3Code": "C3-2026-000671", + "model": "AV-SET-P", + "batchNo": "H7932163", + "registrationNo": "国械注进2019521423", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2023-09-26", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2023-10-29" + }, + { + "c3Code": "C3-2026-000672", + "model": "4-0", + "batchNo": 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"registrationNo": "国械注进2024727562", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2026-03-31", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2026-06-03" + }, + { + "c3Code": "C3-2026-000682", + "model": "IS-5.0", + "batchNo": "H8400949", + "registrationNo": "国械注进2018395416", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2023-12-29", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-02-03" + }, + { + "c3Code": "C3-2026-000683", + "model": "IS-7.0", + "batchNo": "H7443146", + "registrationNo": "国械注进2016258061", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2025-10-11", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-11-04" + }, + { + "c3Code": "C3-2026-000684", + "model": "5-0", + "batchNo": "A6863440", + "registrationNo": "国械注进2018775456", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2025-02-25", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-15" + }, + { + "c3Code": "C3-2026-000685", + "model": "1.4m²", + "batchNo": "G9193385", + "registrationNo": "国械注进2016430689", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-09-15", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-10-30" + }, + { + "c3Code": "C3-2026-000686", + "model": "IS-5.0", + "batchNo": "A2612288", + "registrationNo": "国械注进2019237396", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2025-04-24", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-05-07" + }, + { + "c3Code": "C3-2026-000687", + "model": "1.4m²", + "batchNo": "C2735338", + 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"registrationNo": "国械注进2023649249", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "包装破损", + "registerDate": "2024-04-04", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-04-04" + }, + { + "c3Code": "C3-2026-000694", + "model": "3-0", + "batchNo": "G5194365", + "registrationNo": "国械注进2019355246", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-04-22", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-05-15" + }, + { + "c3Code": "C3-2026-000695", + "model": "4-0", + "batchNo": "A3898641", + "registrationNo": "国械注进2015141886", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2024-11-07", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-12-21" + }, + { + "c3Code": "C3-2026-000696", + "model": "5-0", + "batchNo": "C8942355", + 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+ "registrationNo": "国械注进2023292002", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2024-09-28", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-10-07" + }, + { + "c3Code": "C3-2026-000727", + "model": "IS-5.0", + "batchNo": "B9771494", + "registrationNo": "国械注进2024628165", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2025-12-21", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-12-21" + }, + { + "c3Code": "C3-2026-000728", + "model": "1.4m²", + "batchNo": "H2483457", + "registrationNo": "国械注进2021140463", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "流速异常", + "registerDate": "2024-01-25", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-25" + }, + { + "c3Code": "C3-2026-000729", + "model": "Introcan Safety 20G", + "batchNo": "G8631548", + 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"registrationNo": "国械注进2015935028", + "productName": "可吸收性外科缝线", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2025-11-02", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2025-11-18" + }, + { + "c3Code": "C3-2026-000733", + "model": "24G", + "batchNo": "C8077643", + "registrationNo": "国械注进2016325444", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2024-12-21", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-01-21" + }, + { + "c3Code": "C3-2026-000734", + "model": "24G", + "batchNo": "A2729576", + "registrationNo": "国械注进2015643336", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2024-01-27", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-02-14" + }, + { + "c3Code": "C3-2026-000735", + "model": "IS-5.0", + "batchNo": "G3399111", + "registrationNo": "国械注进2015112998", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2024-09-03", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-10-05" + }, + { + "c3Code": "C3-2026-000736", + "model": "1.3m²", + "batchNo": "E3263993", + "registrationNo": "国械注进2016939321", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2024-01-17", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2024-02-04" + }, + { + "c3Code": "C3-2026-000737", + "model": "PF-5.0", + "batchNo": "B1186545", + "registrationNo": "国械注进2017761625", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2025-07-29", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-10-05" + }, + { + "c3Code": "C3-2026-000738", + "model": "PF-5.0", + "batchNo": "H8868968", + "registrationNo": "国械注进2019426679", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2024-03-28", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-05-13" + }, + { + "c3Code": "C3-2026-000739", + "model": "4-0", + "batchNo": "E1634917", + "registrationNo": "国械注进2021386466", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2023-12-09", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-01-03" + }, + { + "c3Code": "C3-2026-000740", + "model": "4-0", + "batchNo": "H3015288", + "registrationNo": "国械注进2025875454", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2025-07-15", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-08-03" + }, + { + "c3Code": "C3-2026-000741", + "model": "24G", + "batchNo": "H5794902", + "registrationNo": 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+ "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2026-03-27", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2026-04-16" + }, + { + "c3Code": "C3-2026-000745", + "model": "IS-7.0", + "batchNo": "A7716493", + "registrationNo": "国械注进2015815946", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2024-07-17", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-08-11" + }, + { + "c3Code": "C3-2026-000746", + "model": "AV-SET-A", + "batchNo": "H5254567", + "registrationNo": "国械注进2021827250", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "堵塞", + "registerDate": "2024-12-17", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-01-10" + }, + { + "c3Code": "C3-2026-000747", + "model": "IS-5.0", + "batchNo": "C3052095", + "registrationNo": "国械注进2015523917", + 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"productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2023-09-26", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-11-02" + }, + { + "c3Code": "C3-2026-000751", + "model": "4-0", + "batchNo": "G2174120", + "registrationNo": "国械注进2026687013", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2025-06-07", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-06-07" + }, + { + "c3Code": "C3-2026-000752", + "model": "1.4m²", + "batchNo": "D7096911", + "registrationNo": "国械注进2021643601", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2025-12-24", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2026-02-02" + }, + { + "c3Code": "C3-2026-000753", + "model": "PF-5.0", + "batchNo": "B6345901", + "registrationNo": "国械注进2025448761", + "productName": 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"一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2024-11-05", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-11-29" + }, + { + "c3Code": "C3-2026-000757", + "model": "HD-180", + "batchNo": "G7217086", + "registrationNo": "国械注进2018691222", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2026-01-16", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-02-07" + }, + { + "c3Code": "C3-2026-000758", + "model": "AV-SET-A", + "batchNo": "D9501578", + "registrationNo": "国械注进2023812854", + "productName": "血液透析管路", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2026-02-15", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2026-03-01" + }, + { + "c3Code": "C3-2026-000759", + "model": "1.3m²", + "batchNo": "B2418487", + "registrationNo": "国械注进2023281436", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2023-12-07", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-12-07" + }, + { + "c3Code": "C3-2026-000760", + "model": "4-0", + "batchNo": "F8584198", + "registrationNo": "国械注进2023295410", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "标签不清", + "registerDate": "2024-01-05", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-01-26" + }, + { + "c3Code": "C3-2026-000761", + "model": "Introcan Safety 20G", + "batchNo": "E9857155", + "registrationNo": "国械注进2020162717", + "productName": "一次性使用静脉留置针", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "流速异常", + "registerDate": "2025-09-03", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-09-03" + }, + { + "c3Code": "C3-2026-000762", + "model": "24G", + "batchNo": "C8610150", + "registrationNo": "国械注进2019617553", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2025-07-27", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-09-01" + }, + { + "c3Code": "C3-2026-000763", + "model": "5-0", + "batchNo": "H5412818", + "registrationNo": "国械注进2015391876", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2024-02-21", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-03-26" + }, + { + "c3Code": "C3-2026-000764", + "model": "1.4m²", + "batchNo": "F2037430", + "registrationNo": "国械注进2021259485", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-05-20", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-06-29" + }, + { + "c3Code": "C3-2026-000765", + "model": "20G", + "batchNo": "F6728999", + "registrationNo": "国械注进2025472308", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2025-03-03", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-03-30" + }, + { + "c3Code": "C3-2026-000766", + "model": "22G", + "batchNo": "A4106339", + "registrationNo": "国械注进2018900647", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2026-02-14", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2026-02-14" + }, + { + "c3Code": "C3-2026-000767", + "model": "4-0", + "batchNo": "H2394543", + "registrationNo": "国械注进2021954410", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "包装破损", + "registerDate": "2026-03-11", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2026-04-12" + }, + { + "c3Code": "C3-2026-000768", + "model": "IS-5.0", + "batchNo": "A8625520", + "registrationNo": "国械注进2026591367", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2025-08-22", + "isAe": true, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2025-09-16" + }, + { + "c3Code": "C3-2026-000769", + "model": "5-0", + "batchNo": "D3156589", + "registrationNo": "国械注进2022616740", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-08-26", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-09-03" + }, + { + "c3Code": "C3-2026-000770", + "model": "5-0", + "batchNo": "E6057494", + "registrationNo": "国械注进2026695936", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "包装破损", + "registerDate": "2025-09-27", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-10-09" + }, + { + "c3Code": "C3-2026-000771", + "model": "IS-7.0", + "batchNo": "A8834587", + "registrationNo": "国械注进2019764933", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2025-01-05", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-07" + }, + { + "c3Code": "C3-2026-000772", + "model": "1.3m²", + "batchNo": "F4096717", + "registrationNo": "国械注进2019743360", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "断裂", + "registerDate": "2024-04-12", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-05-24" + }, + { + "c3Code": "C3-2026-000773", + "model": "HD-180", + "batchNo": "A6135776", + "registrationNo": "国械注进2022193500", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "断裂", + "registerDate": "2023-08-09", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-09-23" + }, + { + "c3Code": "C3-2026-000774", + "model": "AV-SET-A", + "batchNo": "G9933484", + "registrationNo": "国械注进2025295943", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2024-04-28", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-05-26" + }, + { + "c3Code": "C3-2026-000775", + "model": "AV-SET-P", + "batchNo": "F3957656", + "registrationNo": "国械注进2017191867", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2024-12-17", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-01-11" + }, + { + "c3Code": "C3-2026-000776", + "model": "AV-SET-A", + "batchNo": "G4851647", + "registrationNo": "国械注进2024207876", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2024-03-24", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-04-25" + }, + { + "c3Code": "C3-2026-000777", + "model": "1.4m²", + "batchNo": "H4588907", + "registrationNo": "国械注进2026457092", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2024-01-17", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-03-03" + }, + { + "c3Code": "C3-2026-000778", + "model": "AV-SET-P", + "batchNo": "F7343230", + "registrationNo": "国械注进2026297259", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2026-01-27", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2026-03-12" + }, + { + "c3Code": "C3-2026-000779", + "model": "3-0", + "batchNo": "H6322210", + "registrationNo": "国械注进2017850415", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2024-09-01", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-09-01" + }, + { + "c3Code": "C3-2026-000780", + "model": "Introcan Safety 20G", + "batchNo": "C3271389", + "registrationNo": "国械注进2022868509", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2026-03-11", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2026-03-24" + }, + { + "c3Code": "C3-2026-000781", + "model": "20G", + "batchNo": "H3797674", + "registrationNo": "国械注进2017197126", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-05-30", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-07-12" + }, + { + "c3Code": "C3-2026-000782", + "model": "1.4m²", + "batchNo": "B6666898", + "registrationNo": "国械注进2021143427", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-04-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-05-18" + }, + { + "c3Code": "C3-2026-000783", + "model": "20G", + "batchNo": "C4102219", + "registrationNo": "国械注进2021638406", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2023-10-22", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-10-22" + }, + { + "c3Code": "C3-2026-000784", + "model": "AV-SET-A", + "batchNo": "F4016386", + "registrationNo": "国械注进2019559359", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2024-01-04", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2024-02-16" + }, + { + "c3Code": "C3-2026-000785", + "model": "AV-SET-P", + "batchNo": "C8837299", + "registrationNo": "国械注进2024767531", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2024-03-05", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2024-04-07" + }, + { + "c3Code": "C3-2026-000786", + "model": "AV-SET-A", + "batchNo": "B7341945", + "registrationNo": "国械注进2022127592", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2023-11-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-12-16" + }, + { + "c3Code": "C3-2026-000787", + "model": "3-0", + "batchNo": "H2953004", + "registrationNo": "国械注进2026913313", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "标签不清", + "registerDate": "2025-06-25", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-07-22" + }, + { + "c3Code": "C3-2026-000788", + "model": "HD-180", + "batchNo": "D3378845", + "registrationNo": "国械注进2024308299", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2023-08-11", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2023-08-21" + }, + { + "c3Code": "C3-2026-000789", + "model": "AV-SET-P", + "batchNo": "A5567112", + "registrationNo": "国械注进2026750284", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2025-05-05", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-06-08" + }, + { + "c3Code": "C3-2026-000790", + "model": "HD-180", + "batchNo": "E9260599", + "registrationNo": "国械注进2022300143", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2025-12-20", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2026-01-27" + }, + { + "c3Code": "C3-2026-000791", + "model": "22G", + "batchNo": "D7222781", + "registrationNo": "国械注进2023422805", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2025-12-27", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2026-02-03" + }, + { + "c3Code": "C3-2026-000792", + "model": "AV-SET-P", + "batchNo": "H7069753", + "registrationNo": "国械注进2023972092", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-12-01", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2026-01-04" + }, + { + "c3Code": "C3-2026-000793", + "model": "AV-SET-P", + "batchNo": "D1899588", + "registrationNo": "国械注进2016102847", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2024-03-28", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-05-20" + }, + { + "c3Code": "C3-2026-000794", + "model": "Introcan Safety 20G", + "batchNo": "H6546303", + "registrationNo": "国械注进2018795421", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2024-09-14", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-09-17" + }, + { + "c3Code": "C3-2026-000795", + "model": "4-0", + "batchNo": "F3007561", + "registrationNo": "国械注进2026437264", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2024-01-01", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-01-19" + }, + { + "c3Code": "C3-2026-000796", + "model": "PF-5.0", + "batchNo": "E7941157", + "registrationNo": "国械注进2015938149", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "堵塞", + "registerDate": "2025-06-09", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2025-07-10" + }, + { + "c3Code": "C3-2026-000797", + "model": "1.3m²", + "batchNo": "H8270660", + "registrationNo": "国械注进2026232406", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2024-06-25", + "isAe": false, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2024-08-05" + }, + { + "c3Code": "C3-2026-000798", + "model": "IS-5.0", + "batchNo": "B5009392", + "registrationNo": "国械注进2020327322", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2025-04-23", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-04-27" + }, + { + "c3Code": "C3-2026-000799", + "model": "5-0", + "batchNo": "G2353703", + "registrationNo": "国械注进2019175040", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "标签不清", + "registerDate": "2023-12-21", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2023-12-21" + }, + { + "c3Code": "C3-2026-000800", + "model": "AV-SET-P", + "batchNo": "B4966377", + "registrationNo": "国械注进2018412488", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "堵塞", + "registerDate": "2023-09-11", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2023-10-12" + }, + { + "c3Code": "C3-2026-000801", + "model": "IS-5.0", + "batchNo": "D9266501", + "registrationNo": "国械注进2022934965", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2024-01-26", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-02-12" + }, + { + "c3Code": "C3-2026-000802", + "model": "1.3m²", + "batchNo": "F2640227", + "registrationNo": "国械注进2016153658", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2025-07-27", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-08-29" + }, + { + "c3Code": "C3-2026-000803", + "model": "22G", + "batchNo": "D7311314", + "registrationNo": "国械注进2021171512", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2024-07-23", + "isAe": true, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2024-08-31" + }, + { + "c3Code": "C3-2026-000804", + "model": "4-0", + "batchNo": "D6811735", + "registrationNo": "国械注进2021889247", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2023-09-25", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2023-10-21" + }, + { + "c3Code": "C3-2026-000805", + "model": "3-0", + "batchNo": "C4378961", + "registrationNo": "国械注进2021777891", + "productName": "可吸收性外科缝线", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2025-02-12", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-03-20" + }, + { + "c3Code": "C3-2026-000806", + "model": "24G", + "batchNo": "B6267717", + "registrationNo": "国械注进2025757421", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2023-10-07", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2023-10-07" + }, + { + "c3Code": "C3-2026-000807", + "model": "20G", + "batchNo": "H9887871", + "registrationNo": "国械注进2019290111", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-09-30", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-10-09" + }, + { + "c3Code": "C3-2026-000808", + "model": "AV-SET-P", + "batchNo": "H8801689", + "registrationNo": "国械注进2021147113", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "堵塞", + "registerDate": "2024-08-28", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-10-05" + }, + { + "c3Code": "C3-2026-000809", + "model": "AV-SET-A", + "batchNo": "C3389893", + "registrationNo": "国械注进2025102570", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-10-10", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-10-28" + }, + { + "c3Code": "C3-2026-000810", + "model": "AV-SET-A", + "batchNo": "E5676991", + "registrationNo": "国械注进2021331114", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-05-20", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2025-07-11" + }, + { + "c3Code": "C3-2026-000811", + "model": "Introcan Safety 20G", + "batchNo": "B2804582", + "registrationNo": "国械注进2020463331", + "productName": "一次性使用静脉留置针", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "连接不牢", + "registerDate": "2024-09-23", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-10-16" + }, + { + "c3Code": "C3-2026-000812", + "model": "1.3m²", + "batchNo": "H9139695", + "registrationNo": "国械注进2026193566", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-07-22", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-09-03" + }, + { + "c3Code": "C3-2026-000813", + "model": "3-0", + "batchNo": "B2258506", + "registrationNo": "国械注进2024445344", + "productName": "可吸收性外科缝线", + "hospitalName": "上海市第一人民医院", + "faultType": "包装破损", + "registerDate": "2026-01-10", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2026-02-15" + }, + { + "c3Code": "C3-2026-000814", + "model": "1.4m²", + "batchNo": "D7513583", + "registrationNo": "国械注进2026715052", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2023-10-31", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2023-12-11" + }, + { + "c3Code": "C3-2026-000815", + "model": "Introcan Safety 20G", + "batchNo": "E3578378", + "registrationNo": "国械注进2019443775", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2025-04-02", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-04-06" + }, + { + "c3Code": "C3-2026-000816", + "model": "AV-SET-P", + "batchNo": "G1267622", + "registrationNo": "国械注进2020201330", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2023-08-08", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2023-08-20" + }, + { + "c3Code": "C3-2026-000817", + "model": "IS-5.0", + "batchNo": "A3270723", + "registrationNo": "国械注进2016663713", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2024-06-28", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-08-03" + }, + { + "c3Code": "C3-2026-000818", + "model": "AV-SET-P", + "batchNo": "E8307785", + "registrationNo": "国械注进2026294550", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-12-29", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2026-02-05" + }, + { + "c3Code": "C3-2026-000819", + "model": "PF-5.0", + "batchNo": "G6517239", + "registrationNo": "国械注进2016569784", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "流速异常", + "registerDate": "2025-10-22", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-12-01" + }, + { + "c3Code": "C3-2026-000820", + "model": "22G", + "batchNo": "H7870510", + "registrationNo": "国械注进2024257968", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": "渗漏", + "registerDate": "2025-07-27", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-09-03" + }, + { + "c3Code": "C3-2026-000821", + "model": "PF-5.0", + "batchNo": "F6234206", + "registrationNo": "国械注进2019237261", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2025-12-13", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-02-11" + }, + { + "c3Code": "C3-2026-000822", + "model": "20G", + "batchNo": "F5989500", + "registrationNo": "国械注进2017679491", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2026-02-07", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2026-03-07" + }, + { + "c3Code": "C3-2026-000823", + "model": "IS-7.0", + "batchNo": "H8372683", + "registrationNo": "国械注进2015617321", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "流速异常", + "registerDate": "2025-08-26", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-09-30" + }, + { + "c3Code": "C3-2026-000824", + "model": "HD-180", + "batchNo": "H4813127", + "registrationNo": "国械注进2026287187", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "断裂", + "registerDate": "2023-09-09", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-10-01" + }, + { + "c3Code": "C3-2026-000825", + "model": "AV-SET-A", + "batchNo": "E8109521", + "registrationNo": "国械注进2021924292", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-11-06", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-12-14" + }, + { + "c3Code": "C3-2026-000826", + "model": "24G", + "batchNo": "F1170285", + "registrationNo": "国械注进2026889404", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-08-03", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-09-05" + }, + { + "c3Code": "C3-2026-000827", + "model": "HD-180", + "batchNo": "D1839662", + "registrationNo": "国械注进2018767481", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "流速异常", + "registerDate": "2026-03-04", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-03-24" + }, + { + "c3Code": "C3-2026-000828", + "model": "IS-5.0", + "batchNo": "D1237552", + "registrationNo": "国械注进2022128711", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "堵塞", + "registerDate": "2024-02-03", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2024-03-30" + }, + { + "c3Code": "C3-2026-000829", + "model": "4-0", + "batchNo": "H2005742", + "registrationNo": "国械注进2020130590", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2025-12-08", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2026-01-09" + }, + { + "c3Code": "C3-2026-000830", + "model": "PF-5.0", + "batchNo": "F8900628", + "registrationNo": "国械注进2026225183", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2025-09-14", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-10-23" + }, + { + "c3Code": "C3-2026-000831", + "model": "IS-7.0", + "batchNo": "F4968386", + "registrationNo": "国械注进2022727552", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2024-11-28", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-01-02" + }, + { + "c3Code": "C3-2026-000832", + "model": "1.3m²", + "batchNo": "F8151874", + "registrationNo": "国械注进2020715906", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2023-10-09", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2023-11-15" + }, + { + "c3Code": "C3-2026-000833", + "model": "24G", + "batchNo": "A9942919", + "registrationNo": "国械注进2018679963", + "productName": "一次性使用静脉留置针", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2025-10-05", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-11-18" + }, + { + "c3Code": "C3-2026-000834", + "model": "IS-5.0", + "batchNo": "C8773881", + "registrationNo": "国械注进2021913381", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2025-05-27", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-07-09" + }, + { + "c3Code": "C3-2026-000835", + "model": "HD-180", + "batchNo": "C9009222", + "registrationNo": "国械注进2015192936", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2023-09-17", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-09-21" + }, + { + "c3Code": "C3-2026-000836", + "model": "IS-7.0", + "batchNo": "F7407693", + "registrationNo": "国械注进2026940310", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2025-03-14", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-04-04" + }, + { + "c3Code": "C3-2026-000837", + "model": "Introcan Safety 20G", + "batchNo": "B6265908", + "registrationNo": "国械注进2025574857", + "productName": "一次性使用静脉留置针", + "hospitalName": "上海市第一人民医院", + "faultType": "流速异常", + "registerDate": "2024-10-15", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2024-11-15" + }, + { + "c3Code": "C3-2026-000838", + "model": "22G", + "batchNo": "C2368670", + "registrationNo": "国械注进2015867812", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2024-07-03", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-08-01" + }, + { + "c3Code": "C3-2026-000839", + "model": "IS-7.0", + "batchNo": "D7249208", + "registrationNo": "国械注进2020409315", + "productName": "一次性使用输液器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "标签不清", + "registerDate": "2025-11-21", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-11-30" + }, + { + "c3Code": "C3-2026-000840", + "model": "3-0", + "batchNo": "C5255806", + "registrationNo": "国械注进2020551539", + "productName": "可吸收性外科缝线", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "断裂", + "registerDate": "2026-02-26", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2026-04-03" + }, + { + "c3Code": "C3-2026-000841", + "model": "AV-SET-P", + "batchNo": "H4809813", + "registrationNo": "国械注进2025160662", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2023-11-07", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-01-02" + }, + { + "c3Code": "C3-2026-000842", + "model": "1.4m²", + "batchNo": "D3567355", + "registrationNo": "国械注进2026700038", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2024-04-12", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-06-16" + }, + { + "c3Code": "C3-2026-000843", + "model": "1.3m²", + "batchNo": "F9121860", + "registrationNo": "国械注进2026225248", + "productName": "血液透析器", + "hospitalName": "上海市第一人民医院", + "faultType": "连接不牢", + "registerDate": "2025-07-09", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2025-09-13" + }, + { + "c3Code": "C3-2026-000844", + "model": "4-0", + "batchNo": "F1009255", + "registrationNo": "国械注进2026593582", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "断裂", + "registerDate": "2026-01-13", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-02-21" + }, + { + "c3Code": "C3-2026-000845", + "model": "4-0", + "batchNo": "E4248252", + "registrationNo": "国械注进2020214594", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2023-08-18", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-09-18" + }, + { + "c3Code": "C3-2026-000846", + "model": "22G", + "batchNo": "C9135394", + "registrationNo": "国械注进2025657684", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2024-01-23", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-01-23" + }, + { + "c3Code": "C3-2026-000847", + "model": "1.3m²", + "batchNo": "G8332179", + "registrationNo": "国械注进2022930904", + "productName": "血液透析器", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2025-04-15", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-05-20" + }, + { + "c3Code": "C3-2026-000848", + "model": "5-0", + "batchNo": "A1030713", + "registrationNo": "国械注进2015365941", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2025-02-23", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-04-16" + }, + { + "c3Code": "C3-2026-000849", + "model": "4-0", + "batchNo": "E1050609", + "registrationNo": "国械注进2023517379", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "断裂", + "registerDate": "2024-05-05", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-05-23" + }, + { + "c3Code": "C3-2026-000850", + "model": "IS-7.0", + "batchNo": "D3584748", + "registrationNo": "国械注进2026231799", + "productName": "一次性使用输液器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "流速异常", + "registerDate": "2024-06-07", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-07-20" + }, + { + "c3Code": "C3-2026-000851", + "model": "Introcan Safety 20G", + "batchNo": "G2134950", + "registrationNo": "国械注进2022354171", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2024-07-23", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-08-30" + }, + { + "c3Code": "C3-2026-000852", + "model": "1.3m²", + "batchNo": "H6849797", + "registrationNo": "国械注进2023169836", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "连接不牢", + "registerDate": "2026-01-21", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2026-01-21" + }, + { + "c3Code": "C3-2026-000853", + "model": "20G", + "batchNo": "D5469566", + "registrationNo": "国械注进2018702086", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2024-01-06", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-01-23" + }, + { + "c3Code": "C3-2026-000854", + "model": "4-0", + "batchNo": "C5557957", + "registrationNo": "国械注进2024615320", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2024-12-31", + "isAe": true, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-02-01" + }, + { + "c3Code": "C3-2026-000855", + "model": "4-0", + "batchNo": "F4214289", + "registrationNo": "国械注进2022248986", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2025-04-08", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-04-08" + }, + { + "c3Code": "C3-2026-000856", + "model": "PF-5.0", + "batchNo": "B9021397", + "registrationNo": "国械注进2017301839", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2024-08-24", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-09-27" + }, + { + "c3Code": "C3-2026-000857", + "model": "IS-7.0", + "batchNo": "D2121093", + "registrationNo": "国械注进2016389465", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "堵塞", + "registerDate": "2026-03-18", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2026-04-14" + }, + { + "c3Code": "C3-2026-000858", + "model": "20G", + "batchNo": "F8453971", + "registrationNo": "国械注进2016206790", + "productName": "一次性使用静脉留置针", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2025-03-12", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-03-12" + }, + { + "c3Code": "C3-2026-000859", + "model": "PF-5.0", + "batchNo": "C9063220", + "registrationNo": "国械注进2025104206", + "productName": "一次性使用输液器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2024-02-18", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-03-31" + }, + { + "c3Code": "C3-2026-000860", + "model": "4-0", + "batchNo": "B1601793", + "registrationNo": "国械注进2022144995", + "productName": "可吸收性外科缝线", + "hospitalName": "四川大学华西医院", + "faultType": "断裂", + "registerDate": "2023-09-09", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2023-10-23" + }, + { + "c3Code": "C3-2026-000861", + "model": "1.4m²", + "batchNo": "D8323153", + "registrationNo": "国械注进2026668269", + "productName": "血液透析器", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2024-05-10", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-06-01" + }, + { + "c3Code": "C3-2026-000862", + "model": "4-0", + "batchNo": "F3031701", + "registrationNo": "国械注进2022325603", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2025-04-22", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-05-21" + }, + { + "c3Code": "C3-2026-000863", + "model": "5-0", + "batchNo": "D7817440", + "registrationNo": "国械注进2017576239", + "productName": "可吸收性外科缝线", + "hospitalName": "山东大学齐鲁医院", + "faultType": "断裂", + "registerDate": "2024-05-14", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2024-07-02" + }, + { + "c3Code": "C3-2026-000864", + "model": "IS-5.0", + "batchNo": "F6682284", + "registrationNo": "国械注进2020587497", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "流速异常", + "registerDate": "2026-04-10", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": 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"2024-04-22" + }, + { + "c3Code": "C3-2026-000868", + "model": "HD-180", + "batchNo": "A7956909", + "registrationNo": "国械注进2019335699", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "包装破损", + "registerDate": "2023-09-25", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2023-11-29" + }, + { + "c3Code": "C3-2026-000869", + "model": "AV-SET-P", + "batchNo": "B7689471", + "registrationNo": "国械注进2017760922", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2023-12-22", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-02-03" + }, + { + "c3Code": "C3-2026-000870", + "model": "AV-SET-A", + "batchNo": "H5410690", + "registrationNo": "国械注进2018603082", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2025-06-26", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-08-10" 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{ + "c3Code": "C3-2026-000874", + "model": "3-0", + "batchNo": "B5922750", + "registrationNo": "国械注进2016663429", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2024-01-30", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-03-04" + }, + { + "c3Code": "C3-2026-000875", + "model": "AV-SET-P", + "batchNo": "H9748177", + "registrationNo": "国械注进2019351409", + "productName": "血液透析管路", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2024-03-12", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-04-05" + }, + { + "c3Code": "C3-2026-000876", + "model": "1.3m²", + "batchNo": "H5840607", + "registrationNo": "国械注进2020614995", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2023-10-21", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2023-11-30" + }, + { + "c3Code": "C3-2026-000877", + "model": "AV-SET-P", + "batchNo": "H6117786", + "registrationNo": "国械注进2018568650", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "渗漏", + "registerDate": "2026-02-15", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2026-04-26" + }, + { + "c3Code": "C3-2026-000878", + "model": "24G", + "batchNo": "C4949316", + "registrationNo": "国械注进2025504695", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2025-05-07", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2025-06-05" + }, + { + "c3Code": "C3-2026-000879", + "model": "IS-5.0", + "batchNo": "F4202479", + "registrationNo": "国械注进2020281288", + "productName": "一次性使用输液器", + "hospitalName": "上海市第一人民医院", + "faultType": "标签不清", + "registerDate": "2024-12-29", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-01-23" + }, + { + "c3Code": "C3-2026-000880", + "model": "4-0", + "batchNo": "E4952050", + "registrationNo": "国械注进2018804278", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2024-05-21", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-05-21" + }, + { + "c3Code": "C3-2026-000881", + "model": "4-0", + "batchNo": "G4879095", + "registrationNo": "国械注进2018822408", + "productName": "可吸收性外科缝线", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2023-11-03", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-12-31" + }, + { + "c3Code": "C3-2026-000882", + "model": "AV-SET-P", + "batchNo": "E4352567", + "registrationNo": "国械注进2018124753", + "productName": "血液透析管路", + "hospitalName": "上海市第一人民医院", + "faultType": "堵塞", + "registerDate": "2023-09-26", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2023-10-22" + }, + { + "c3Code": "C3-2026-000883", + "model": "22G", + "batchNo": "E7567198", + "registrationNo": "国械注进2018607337", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "包装破损", + "registerDate": "2025-05-13", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-05-13" + }, + { + "c3Code": "C3-2026-000884", + "model": "20G", + "batchNo": "A2362036", + "registrationNo": "国械注进2024372041", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "渗漏", + "registerDate": "2025-02-07", + "isAe": true, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-03-02" + }, + { + "c3Code": "C3-2026-000885", + "model": "AV-SET-P", + "batchNo": "F6809288", + "registrationNo": "国械注进2024834149", + "productName": "血液透析管路", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-11-10", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-12-27" + }, + { + "c3Code": "C3-2026-000886", + "model": "1.3m²", + "batchNo": "A1932257", + "registrationNo": "国械注进2026105601", + "productName": "血液透析器", + "hospitalName": "四川大学华西医院", + "faultType": "断裂", + "registerDate": "2024-02-22", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-02-22" + }, + { + "c3Code": "C3-2026-000887", + "model": "3-0", + "batchNo": "H4285859", + "registrationNo": "国械注进2022137605", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2024-08-13", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-08-13" + }, + { + "c3Code": "C3-2026-000888", + "model": "AV-SET-P", + "batchNo": "D4497760", + "registrationNo": "国械注进2026855065", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "连接不牢", + "registerDate": "2025-04-28", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-05-19" + }, + { + "c3Code": "C3-2026-000889", + 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"productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2025-03-16", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2025-03-16" + }, + { + "c3Code": "C3-2026-000947", + "model": "1.3m²", + "batchNo": "D2234139", + "registrationNo": "国械注进2023213350", + "productName": "血液透析器", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2025-04-29", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2025-06-07" + }, + { + "c3Code": "C3-2026-000948", + "model": "IS-7.0", + "batchNo": "B5567616", + "registrationNo": "国械注进2018597806", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2024-09-09", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-09-09" + }, + { + "c3Code": "C3-2026-000949", + "model": "3-0", + "batchNo": "D2540277", + "registrationNo": "国械注进2021613229", + "productName": 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"hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2026-02-04", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2026-02-04" + }, + { + "c3Code": "C3-2026-000953", + "model": "HD-180", + "batchNo": "F3076901", + "registrationNo": "国械注进2021315016", + "productName": "血液透析器", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2025-12-28", + "isAe": false, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2026-01-27" + }, + { + "c3Code": "C3-2026-000954", + "model": "5-0", + "batchNo": "F1702082", + "registrationNo": "国械注进2021922167", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "断裂", + "registerDate": "2025-02-25", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-03-03" + }, + { + "c3Code": "C3-2026-000955", + "model": "Introcan Safety 20G", + "batchNo": "H3681620", + "registrationNo": "国械注进2015390278", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "包装破损", + "registerDate": "2023-08-13", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2023-09-21" + }, + { + "c3Code": "C3-2026-000956", + "model": "20G", + "batchNo": "H5013480", + "registrationNo": "国械注进2020416038", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2023-12-22", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-02-09" + }, + { + "c3Code": "C3-2026-000957", + "model": "4-0", + "batchNo": "C6691089", + "registrationNo": "国械注进2017715781", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2025-06-14", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2025-06-14" + }, + { + "c3Code": "C3-2026-000958", + "model": "1.3m²", + "batchNo": "A4179064", + "registrationNo": "国械注进2020861144", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-10-28", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-11-12" + }, + { + "c3Code": "C3-2026-000959", + "model": "22G", + "batchNo": "D7510799", + "registrationNo": "国械注进2024421297", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2025-03-16", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2025-03-16" + }, + { + "c3Code": "C3-2026-000960", + "model": "IS-5.0", + "batchNo": "C4326582", + "registrationNo": "国械注进2021603773", + "productName": "一次性使用输液器", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2024-09-01", + "isAe": false, + "conclusion": "未复现", + "compensation": "折让", + "closeDate": "2024-09-14" + }, + { + "c3Code": "C3-2026-000961", + "model": "5-0", + "batchNo": "F6261338", + "registrationNo": "国械注进2019321909", + "productName": "可吸收性外科缝线", + "hospitalName": "广东省人民医院", + "faultType": "标签不清", + "registerDate": "2026-04-13", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2026-05-05" + }, + { + "c3Code": "C3-2026-000962", + "model": "PF-5.0", + "batchNo": "A9237165", + "registrationNo": "国械注进2020666714", + "productName": "一次性使用输液器", + "hospitalName": "福建省立医院", + "faultType": "堵塞", + "registerDate": "2023-08-15", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2023-10-08" + }, + { + "c3Code": "C3-2026-000963", + "model": "AV-SET-P", + "batchNo": "B1300313", + "registrationNo": "国械注进2024923441", + "productName": "血液透析管路", + "hospitalName": "南京鼓楼医院", + "faultType": "渗漏", + "registerDate": "2024-09-11", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2024-09-11" + }, + { + "c3Code": "C3-2026-000964", + "model": "4-0", + "batchNo": "F1421025", + "registrationNo": "国械注进2017147397", + "productName": "可吸收性外科缝线", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "断裂", + "registerDate": "2024-07-27", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2024-09-14" + }, + { + "c3Code": "C3-2026-000965", + "model": "24G", + "batchNo": "F9895469", + "registrationNo": "国械注进2024303250", + "productName": "一次性使用静脉留置针", + "hospitalName": "福建省立医院", + "faultType": "连接不牢", + "registerDate": "2026-03-07", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2026-03-26" + }, + { + "c3Code": "C3-2026-000966", + "model": "24G", + "batchNo": "C2573880", + "registrationNo": "国械注进2022521728", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-03-07", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2024-03-20" + }, + { + "c3Code": "C3-2026-000967", + "model": "AV-SET-A", + "batchNo": "B8166586", + "registrationNo": "国械注进2024371195", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "渗漏", + "registerDate": "2025-01-07", + "isAe": false, + "conclusion": "资料不足", + "compensation": "无赔付", + "closeDate": "2025-01-07" + }, + { + "c3Code": "C3-2026-000968", + "model": "AV-SET-A", + "batchNo": "E1854865", + "registrationNo": "国械注进2021747716", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2025-02-02", + "isAe": false, + "conclusion": "资料不足", + "compensation": "折让", + "closeDate": "2025-03-08" + }, + { + "c3Code": "C3-2026-000969", + "model": "1.4m²", + "batchNo": "G6169594", + "registrationNo": "国械注进2022562082", + "productName": "血液透析器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "流速异常", + "registerDate": "2024-05-03", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "无赔付", + "closeDate": "2024-05-26" + }, + { + "c3Code": "C3-2026-000970", + "model": "AV-SET-A", + "batchNo": "C8390398", + "registrationNo": "国械注进2025975706", + "productName": "血液透析管路", + "hospitalName": "山东大学齐鲁医院", + "faultType": "堵塞", + "registerDate": "2024-12-27", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-01-27" + }, + { + "c3Code": "C3-2026-000971", + "model": "3-0", + "batchNo": "F9209714", + "registrationNo": "国械注进2021722461", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2025-05-03", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2025-05-03" + }, + { + "c3Code": "C3-2026-000972", + "model": "Introcan Safety 20G", + "batchNo": "B6199453", + "registrationNo": "国械注进2016909755", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "渗漏", + "registerDate": "2024-06-23", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "退款", + "closeDate": "2024-08-02" + }, + { + "c3Code": "C3-2026-000973", + "model": "HD-180", + "batchNo": "G3164290", + "registrationNo": "国械注进2026349003", + "productName": "血液透析器", + "hospitalName": "中南大学湘雅医院", + "faultType": "包装破损", + "registerDate": "2024-01-27", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2024-03-11" + }, + { + "c3Code": "C3-2026-000974", + "model": "IS-7.0", + "batchNo": "C4186958", + "registrationNo": "国械注进2025888942", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "堵塞", + "registerDate": "2023-12-28", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-01-11" + }, + { + "c3Code": "C3-2026-000975", + "model": "3-0", + "batchNo": "C9829318", + "registrationNo": "国械注进2022794663", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "标签不清", + "registerDate": "2024-05-21", + "isAe": false, + "conclusion": "操作不当", + "compensation": "折让", + "closeDate": "2024-07-08" + }, + { + "c3Code": "C3-2026-000976", + "model": "AV-SET-P", + "batchNo": "B2565857", + "registrationNo": "国械注进2019356767", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "连接不牢", + "registerDate": "2026-03-09", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2026-03-23" + }, + { + "c3Code": "C3-2026-000977", + "model": "Introcan Safety 20G", + "batchNo": "A4408615", + "registrationNo": "国械注进2022263470", + "productName": "一次性使用静脉留置针", + "hospitalName": "南京鼓楼医院", + "faultType": "包装破损", + "registerDate": "2024-07-02", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-09-07" + }, + { + "c3Code": "C3-2026-000978", + "model": "1.4m²", + "batchNo": "H5289138", + "registrationNo": "国械注进2022585056", + "productName": "血液透析器", + "hospitalName": "山东大学齐鲁医院", + "faultType": "流速异常", + "registerDate": "2024-07-20", + "isAe": false, + "conclusion": "未复现", + "compensation": "其他协商处理", + "closeDate": "2024-08-14" + }, + { + "c3Code": "C3-2026-000979", + "model": "IS-5.0", + "batchNo": "A8085079", + "registrationNo": "国械注进2025214994", + "productName": "一次性使用输液器", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "标签不清", + "registerDate": "2025-11-29", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2025-11-29" + }, + { + "c3Code": "C3-2026-000980", + "model": "IS-7.0", + "batchNo": "G4069745", + "registrationNo": "国械注进2021897614", + "productName": "一次性使用输液器", + "hospitalName": "南京鼓楼医院", + "faultType": "流速异常", + "registerDate": "2025-06-14", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-06-27" + }, + { + "c3Code": "C3-2026-000981", + "model": "Introcan Safety 20G", + "batchNo": "F2654677", + "registrationNo": "国械注进2021506086", + "productName": "一次性使用静脉留置针", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2025-05-09", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2025-06-08" + }, + { + "c3Code": "C3-2026-000982", + "model": "24G", + "batchNo": "B6433079", + "registrationNo": "国械注进2019148503", + "productName": "一次性使用静脉留置针", + "hospitalName": "山东大学齐鲁医院", + "faultType": 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"2023-09-16", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "折让", + "closeDate": "2023-09-16" + }, + { + "c3Code": "C3-2026-000986", + "model": "3-0", + "batchNo": "B5474131", + "registrationNo": "国械注进2015292284", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2026-01-17", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2026-02-02" + }, + { + "c3Code": "C3-2026-000987", + "model": "1.3m²", + "batchNo": "C6756494", + "registrationNo": "国械注进2025156576", + "productName": "血液透析器", + "hospitalName": "西安交通大学第一附属医院", + "faultType": "连接不牢", + "registerDate": "2024-01-12", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-01-15" + }, + { + "c3Code": "C3-2026-000988", + "model": "24G", + "batchNo": "F4170762", + "registrationNo": "国械注进2017458522", + "productName": "一次性使用静脉留置针", + "hospitalName": "郑州大学第一附属医院", + "faultType": "包装破损", + "registerDate": "2024-07-11", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "折让", + "closeDate": "2024-07-20" + }, + { + "c3Code": "C3-2026-000989", + "model": "IS-5.0", + "batchNo": "H2908722", + "registrationNo": "国械注进2021259724", + "productName": "一次性使用输液器", + "hospitalName": "四川大学华西医院", + "faultType": "流速异常", + "registerDate": "2024-06-23", + "isAe": true, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-08-05" + }, + { + "c3Code": "C3-2026-000990", + "model": "Introcan Safety 20G", + "batchNo": "D3465840", + "registrationNo": "国械注进2018920947", + "productName": "一次性使用静脉留置针", + "hospitalName": "广东省人民医院", + "faultType": "连接不牢", + "registerDate": "2026-03-10", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "退款", + "closeDate": "2026-03-13" + }, + { + "c3Code": "C3-2026-000991", + "model": "AV-SET-P", + "batchNo": "E9366904", + "registrationNo": "国械注进2025456116", + "productName": "血液透析管路", + "hospitalName": "福建省立医院", + "faultType": "堵塞", + "registerDate": "2024-01-21", + "isAe": true, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2024-02-22" + }, + { + "c3Code": "C3-2026-000992", + "model": "4-0", + "batchNo": "B1850695", + "registrationNo": "国械注进2017346139", + "productName": "可吸收性外科缝线", + "hospitalName": "郑州大学第一附属医院", + "faultType": "断裂", + "registerDate": "2025-05-09", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-05-16" + }, + { + "c3Code": "C3-2026-000993", + "model": "AV-SET-P", + "batchNo": "H6360833", + "registrationNo": "国械注进2020904279", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2023-10-08", + "isAe": false, + "conclusion": "操作不当", + "compensation": "无赔付", + "closeDate": "2023-10-08" + }, + { + "c3Code": "C3-2026-000994", + "model": "IS-7.0", + "batchNo": "C8833763", + "registrationNo": "国械注进2026302944", + "productName": "一次性使用输液器", + "hospitalName": "中南大学湘雅医院", + "faultType": "标签不清", + "registerDate": "2024-02-26", + "isAe": false, + "conclusion": "未复现", + "compensation": "无赔付", + "closeDate": "2024-04-03" + }, + { + "c3Code": "C3-2026-000995", + "model": "AV-SET-A", + "batchNo": "H3409477", + "registrationNo": "国械注进2018269173", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "渗漏", + "registerDate": "2025-03-01", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "换货", + "closeDate": "2025-03-01" + }, + { + "c3Code": "C3-2026-000996", + "model": "AV-SET-A", + "batchNo": "B4216157", + "registrationNo": "国械注进2024734527", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "堵塞", + "registerDate": "2025-08-08", + "isAe": true, + "conclusion": "操作不当", + "compensation": "其他协商处理", + "closeDate": "2025-09-03" + }, + { + "c3Code": "C3-2026-000997", + "model": "AV-SET-A", + "batchNo": "B7205873", + "registrationNo": "国械注进2026549557", + "productName": "血液透析管路", + "hospitalName": "浙江大学医学院附属第二医院", + "faultType": "连接不牢", + "registerDate": "2024-11-16", + "isAe": false, + "conclusion": "产品缺陷成立", + "compensation": "换货", + "closeDate": "2024-12-11" + }, + { + "c3Code": "C3-2026-000998", + "model": "AV-SET-A", + "batchNo": "C7706722", + "registrationNo": "国械注进2020696436", + "productName": "血液透析管路", + "hospitalName": "中南大学湘雅医院", + "faultType": "渗漏", + "registerDate": "2026-03-10", + "isAe": true, + "conclusion": "资料不足", + "compensation": "其他协商处理", + "closeDate": "2026-04-24" + }, + { + "c3Code": "C3-2026-000999", + "model": "5-0", + "batchNo": "C5939734", + "registrationNo": "国械注进2015613076", + "productName": "可吸收性外科缝线", + "hospitalName": "福建省立医院", + "faultType": "包装破损", + "registerDate": "2025-07-04", + "isAe": true, + "conclusion": "运输损伤", + "compensation": "其他协商处理", + "closeDate": "2025-08-24" + }, + { + "c3Code": "C3-2026-001000", + "model": "AV-SET-A", + "batchNo": "E7571174", + "registrationNo": "国械注进2020676368", + "productName": "血液透析管路", + "hospitalName": "四川大学华西医院", + "faultType": "连接不牢", + "registerDate": "2026-03-05", + "isAe": false, + "conclusion": "运输损伤", + "compensation": "无赔付", + "closeDate": "2026-03-05" + } +] \ No newline at end of file diff --git a/analytics-demo-web/src/App.vue b/analytics-demo-web/src/App.vue new file mode 100644 index 0000000..98240ae --- /dev/null +++ b/analytics-demo-web/src/App.vue @@ -0,0 +1,3 @@ + diff --git a/analytics-demo-web/src/assets/hero.png b/analytics-demo-web/src/assets/hero.png new file mode 100644 index 0000000..cc51a3d Binary files /dev/null and b/analytics-demo-web/src/assets/hero.png differ diff --git a/analytics-demo-web/src/assets/styles/common.scss b/analytics-demo-web/src/assets/styles/common.scss new file mode 100644 index 0000000..b0f4289 --- /dev/null +++ b/analytics-demo-web/src/assets/styles/common.scss @@ -0,0 +1,69 @@ +/* 页面布局与卡片（规范 4.2 / 4.3 子集） */ +.page-container { + padding: var(--padding-md); + min-height: 100%; + box-sizing: border-box; +} + +.page-container-toolbar { + display: flex; + justify-content: flex-end; + margin-bottom: var(--padding-md); +} + +.page-header { + margin-bottom: var(--padding-lg); +} + +.header-content { + display: flex; + justify-content: space-between; + align-items: flex-start; + gap: var(--padding-md); + flex-wrap: wrap; +} + +.header-left { + flex: 1; + min-width: 200px; +} + +.page-title { + margin: 0 0 8px; + font-size: 22px; + font-weight: 600; + color: var(--text-primary); + display: flex; + align-items: center; + gap: 8px; +} + +.page-description { + margin: 0; + font-size: 14px; + color: var(--text-secondary); + line-height: 1.6; +} + +.header-actions { + flex-shrink: 0; +} + +.meta-tags { + display: flex; + flex-wrap: wrap; + gap: 8px; +} + +.main-card { + margin-bottom: var(--padding-md); + border-radius: var(--border-radius-md); +} + +.main-card:last-child { + margin-bottom: 0; +} + +.module-content { + padding: var(--padding-md) 0 0; +} diff --git a/analytics-demo-web/src/assets/styles/index.scss b/analytics-demo-web/src/assets/styles/index.scss new file mode 100644 index 0000000..ad4e177 --- /dev/null +++ b/analytics-demo-web/src/assets/styles/index.scss @@ -0,0 +1,32 @@ +/* 设计令牌（与《前端技术设计规范》对齐的子集） */ +:root { + --customer-board-color: #409eff; + --padding-md: 16px; + --padding-lg: 24px; + --border-radius-md: 8px; + --text-primary: #303133; + --text-secondary: #606266; + --text-placeholder: #909399; + --border-color: #ebeef5; + --bg-color: #f5f7fa; +} + +html, +body, +#app { + height: 100%; +} + +body { + margin: 0; + font-family: + 'Helvetica Neue', + Helvetica, + 'PingFang SC', + 'Hiragino Sans GB', + 'Microsoft YaHei', + Arial, + sans-serif; + color: var(--text-primary); + background: var(--bg-color); +} diff --git a/analytics-demo-web/src/assets/vite.svg b/analytics-demo-web/src/assets/vite.svg new file mode 100644 index 0000000..5101b67 --- /dev/null +++ b/analytics-demo-web/src/assets/vite.svg @@ -0,0 +1 @@ +Vite diff --git a/analytics-demo-web/src/assets/vue.svg b/analytics-demo-web/src/assets/vue.svg new file mode 100644 index 0000000..770e9d3 --- /dev/null +++ b/analytics-demo-web/src/assets/vue.svg @@ -0,0 +1 @@ + \ No newline at end of file diff --git a/analytics-demo-web/src/components/HelloWorld.vue b/analytics-demo-web/src/components/HelloWorld.vue new file mode 100644 index 0000000..5917e16 --- /dev/null +++ b/analytics-demo-web/src/components/HelloWorld.vue @@ -0,0 +1,93 @@ + + + diff --git a/analytics-demo-web/src/components/PageContainer.vue b/analytics-demo-web/src/components/PageContainer.vue new file mode 100644 index 0000000..a2cc367 --- /dev/null +++ b/analytics-demo-web/src/components/PageContainer.vue @@ -0,0 +1,31 @@ + + + diff --git a/analytics-demo-web/src/components/charts/ChartCard.vue b/analytics-demo-web/src/components/charts/ChartCard.vue new file mode 100644 index 0000000..cf3ec04 --- /dev/null +++ b/analytics-demo-web/src/components/charts/ChartCard.vue @@ -0,0 +1,145 @@ + + + + + diff --git a/analytics-demo-web/src/composables/useAnalysisContext.ts b/analytics-demo-web/src/composables/useAnalysisContext.ts new file mode 100644 index 0000000..bb0b398 --- /dev/null +++ b/analytics-demo-web/src/composables/useAnalysisContext.ts @@ -0,0 +1,32 @@ +import { onMounted, ref, shallowRef } from 'vue' +import type { AnalysisContext } from '@/types/analysis' +import { invalidateAnalysisContextCache, loadAnalysisContext } from '@/lib/mock-data' + +export interface UseAnalysisContextOptions { + /** 挂载时是否立即加载，默认 true */ + immediate?: boolean +} + +export function useAnalysisContext(options: UseAnalysisContextOptions = {}) { + const immediate = options.immediate !== false + const context = shallowRef(null) + const loading = ref(false) + + async function reload(): Promise { + loading.value = true + try { + invalidateAnalysisContextCache() + context.value = await loadAnalysisContext() + } finally { + loading.value = false + } + } + + onMounted(() => { + if (immediate) { + void reload() + } + }) + + return { context, loading, reload } +} diff --git a/analytics-demo-web/src/config/analysis-config.ts b/analytics-demo-web/src/config/analysis-config.ts new file mode 100644 index 0000000..ea78744 --- /dev/null +++ b/analytics-demo-web/src/config/analysis-config.ts @@ -0,0 +1,1383 @@ +import type { EChartsOption } from 'echarts' +import type { AnalysisContext, AnalysisPageDefinition, ChartDefinition } from '../types/analysis' +import { + buildAeMonthlyByOccurrence, + buildComplaintPareto, + buildComplianceMatching, + buildGlobalMonthlyPpm, + buildInjuryDeviceMatrix, + buildProvinceAeCounts, + buildPsurTopProducts, + buildReportingLagDays, + buildSaeMonthlyByOccurrence, + buildSaeShareMonthly, + buildTopDeviceFailures, +} from '../lib/aggregate' +import { + buildBatchComplaintVsAeCounts, + buildComplaintBatchTop, + buildComplaintCloseCycleDays, + buildComplaintMonthly, + buildCompensationDist, + buildDefectConfirmedProductFault, + buildFaultByRegisterMonthMatrix, + buildHospitalAeVsAdmissionScatter, + buildHospitalComplaintVsAdmissionQty, + buildHospitalProductComplaintRate, + buildInvestigationConclusionDist, + buildIsAeRateByProduct, + buildProductComplaintHalfYearGrowth, + buildProvinceComplaintHalfYearGrowth, + buildTopFaultTypes, + buildTopHospitalsComplaints, + buildTopProductsComplaints, +} from '../lib/quality-aggregate' +import { + COMPLIANCE_DOC_REF, + COMPLIANCE_FOOTNOTE_AUDIT, + COMPLIANCE_FOOTNOTE_PPM, + COMPLIANCE_FOOTNOTE_SHORT, +} from './compliance-baseline' +import { QUALITY_DOC_REF, QLT_ADMISSION_DENOM, QLT_TIME_AXIS } from './quality-baseline' +import { + buildDealerComplaintRatePer1000, + buildDealerOpWrongRatePer1000, + buildOpWrongDealerCounts, + buildOpWrongHospitalTop, + buildProductOpWrongSharePct, + buildProvinceComplaintCounts, + buildProvinceComplaintRatePer1000, +} from '../lib/marketing-aggregate' +import { MARKETING_DOC_REF, MKT_ADMISSION_DENOM, MKT_HOSPITAL_MAP, MKT_TIME_AXIS } from './marketing-baseline' + +const MOCK_DATA_SCOPE = + '数据源：前端 fetch 加载 public/mock 下 ae.json、complaint.json、admission.json 的全量记录；未接入 Pinia 全局年份/BU 筛选（上线后与数仓条件对齐）。' + +const ex = (extraScope: string, analysisLogic: string) => ({ + dataScope: [MOCK_DATA_SCOPE, extraScope].filter(Boolean).join(' '), + analysisLogic, +}) + +const placeholderPair = (prefix: string, hint = '见主策略对应小节与落地文档指标编码。'): ChartDefinition[] => [ + { + id: `${prefix}-1`, + title: '图表位 A（待接数据）', + placeholder: true, + chartExplain: ex('暂无聚合结果。', `占位图表；实现时替换为 optionBuilder，并满足「取数范围 + 分析逻辑」说明要求。${hint}`), + }, + { + id: `${prefix}-2`, + title: '图表位 B（待接数据）', + placeholder: true, + chartExplain: ex('暂无聚合结果。', `同上。${hint}`), + }, +] + +const lineOption = ( + title: string, + xAxis: string[], + seriesData: (number | null)[], + seriesName = '事件数', + subtext?: string, +): EChartsOption => ({ + title: { + text: title, + subtext, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: subtext ? 78 : 60, right: 24, bottom: 40, left: 40 }, + xAxis: { type: 'category', data: xAxis }, + yAxis: { type: 'value' }, + series: [{ name: seriesName, type: 'line', smooth: true, data: seriesData }], +}) + +const barOption = (title: string, labels: string[], values: number[], subtext?: string): EChartsOption => ({ + title: { + text: title, + subtext, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: subtext ? 78 : 60, right: 24, bottom: 60, left: 45 }, + xAxis: { type: 'category', data: labels, axisLabel: { rotate: 20 } }, + yAxis: { type: 'value' }, + series: [{ type: 'bar', data: values, itemStyle: { borderRadius: [4, 4, 0, 0] } }], +}) + +const injuryDeviceHeatmapOption = (saeOnly: boolean, title: string, subtext: string) => { + return (context: AnalysisContext): EChartsOption => { + const { injuries, devices, cells } = buildInjuryDeviceMatrix(context, saeOnly) + const data = cells.map((c) => [devices.indexOf(c.device), injuries.indexOf(c.injury), c.value]) + const max = Math.max(1, ...cells.map((c) => c.value)) + return { + title: { + text: title, + subtext, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { position: 'top' }, + grid: { top: 88, height: Math.max(220, injuries.length * 28), left: 80, right: 24, bottom: 48 }, + xAxis: { type: 'category', data: devices, splitArea: { show: true } }, + yAxis: { type: 'category', data: injuries, splitArea: { show: true } }, + visualMap: { + min: 0, + max, + calculable: true, + orient: 'horizontal', + left: 'center', + bottom: 4, + inRange: { color: ['#eef2ff', '#312e81'] }, + }, + series: [ + { + name: '报告条数', + type: 'heatmap', + data, + label: { show: true }, + emphasis: { itemStyle: { shadowBlur: 10, shadowColor: 'rgba(0,0,0,0.3)' } }, + }, + ], + } + } +} + +const reportingLagHistogramOption = (context: AnalysisContext): EChartsOption => { + const lags = buildReportingLagDays(context).filter((d) => d >= 0) + const bins = ['0–1', '2–3', '4–5', '6–7', '8–10', '>10'] + const counts = [0, 0, 0, 0, 0, 0] + lags.forEach((d) => { + if (d <= 1) counts[0] += 1 + else if (d <= 3) counts[1] += 1 + else if (d <= 5) counts[2] += 1 + else if (d <= 7) counts[3] += 1 + else if (d <= 10) counts[4] += 1 + else counts[5] += 1 + }) + return { + title: { + text: '上报滞后天数分布（审核日期 − 登记日期）', + subtext: `${COMPLIANCE_DOC_REF}｜CMP-AE-701`, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: 88, right: 24, bottom: 40, left: 40 }, + xAxis: { type: 'category', data: bins }, + yAxis: { type: 'value', name: 'AE 条数' }, + series: [{ type: 'bar', data: counts, itemStyle: { borderRadius: [4, 4, 0, 0] } }], + } +} + +const complianceAuditSummaryOption = (context: AnalysisContext): EChartsOption => { + const m = buildComplianceMatching(context) + return { + title: { + text: '上报合规审计摘要', + subtext: COMPLIANCE_FOOTNOTE_AUDIT, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + legend: { top: 72, data: ['占比%'] }, + grid: { top: 110, right: 24, bottom: 56, left: 48 }, + xAxis: { + type: 'category', + data: ['漏报率', '匹配率', '时效(登记)', '时效(C3)'], + axisLabel: { interval: 0, rotate: 0 }, + }, + yAxis: { type: 'value', name: '%', max: 100 }, + series: [ + { + name: '占比%', + type: 'bar', + data: [m.leakRate, m.matchRate, m.timelinessFromRegistrationPct, m.timelinessFromC3Pct], + itemStyle: { borderRadius: [4, 4, 0, 0] }, + }, + ], + } +} + +const complianceAuditCountsOption = (context: AnalysisContext): EChartsOption => { + const m = buildComplianceMatching(context) + return { + title: { + text: '应报样本量（投诉 isAe=是）', + subtext: `基准 ${m.flaggedTotal} 条｜匹配 ${m.matched}｜疑似漏报 ${m.missed}｜CMP-CV-101~104`, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'item' }, + series: [ + { + type: 'pie', + radius: ['36%', '62%'], + label: { formatter: '{b}: {c} ({d}%)' }, + data: [ + { name: '已匹配', value: m.matched }, + { name: '疑似漏报', value: m.missed }, + ], + }, + ], + } +} + +const paretoOption = (context: AnalysisContext): EChartsOption => { + const pareto = buildComplaintPareto(context) + return { + title: { text: '产品×故障 Pareto', left: 'center', textStyle: { fontSize: 14 } }, + tooltip: { trigger: 'axis' }, + legend: { top: 30, data: ['投诉数', '累计占比%'] }, + grid: { top: 70, right: 50, bottom: 70, left: 45 }, + xAxis: { type: 'category', data: pareto.labels, axisLabel: { rotate: 25 } }, + yAxis: [{ type: 'value', name: '投诉数' }, { type: 'value', name: '累计%', max: 100 }], + series: [ + { name: '投诉数', type: 'bar', data: pareto.bars }, + { name: '累计占比%', type: 'line', yAxisIndex: 1, smooth: true, data: pareto.line }, + ], + } +} + +const faultSeasonalityHeatmapOption = (context: AnalysisContext): EChartsOption => { + const { faults, months, cells } = buildFaultByRegisterMonthMatrix(context) + const max = Math.max(1, ...cells.map((c) => c.value)) + const data = cells.map((c) => [months.indexOf(c.month), faults.indexOf(c.fault), c.value]) + return { + title: { + text: '故障类型 × C3登记月（投诉热力）', + subtext: `${QUALITY_DOC_REF}｜主策略 §5.2 与 QLT-BTH-203 月份桶一致`, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { position: 'top' }, + grid: { top: 88, height: Math.max(220, faults.length * 26), left: 100, right: 24, bottom: 48 }, + xAxis: { type: 'category', data: months, splitArea: { show: true } }, + yAxis: { type: 'category', data: faults, splitArea: { show: true } }, + visualMap: { + min: 0, + max, + calculable: true, + orient: 'horizontal', + left: 'center', + bottom: 4, + inRange: { color: ['#ecfdf5', '#065f46'] }, + }, + series: [{ name: '投诉条数', type: 'heatmap', data, label: { show: true } }], + } +} + +const closeCycleHistogramOption = (context: AnalysisContext): EChartsOption => { + const days = buildComplaintCloseCycleDays(context) + const bins = ['0–7', '8–14', '15–30', '31–60', '>60'] + const counts = [0, 0, 0, 0, 0] + days.forEach((d) => { + if (d <= 7) counts[0] += 1 + else if (d <= 14) counts[1] += 1 + else if (d <= 30) counts[2] += 1 + else if (d <= 60) counts[3] += 1 + else counts[4] += 1 + }) + return { + title: { + text: '投诉关闭周期分布', + subtext: 'QLT-RPT-802｜关闭日期 − C3登记日期', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: 80, right: 24, bottom: 40, left: 44 }, + xAxis: { type: 'category', data: bins }, + yAxis: { type: 'value', name: '投诉条数' }, + series: [{ type: 'bar', data: counts, itemStyle: { borderRadius: [4, 4, 0, 0] } }], + } +} + +const hospitalAeScatterOption = (context: AnalysisContext): EChartsOption => { + const pts = buildHospitalAeVsAdmissionScatter(context) + const data = pts.map((p) => [p.cyQty, p.aeCount, p.hospital]) + return { + title: { + text: '医院：AE 条数 vs 入院 cyQty 汇总', + subtext: 'QLT-AE-1003｜AE 按单位名称计数；入院量按医院汇总', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { + formatter: (params: unknown) => { + const p = params as { value?: [number, number, string] } + const v = p.value + if (!v) return '' + return `${v[2]}
cyQty：${v[0]}
AE：${v[1]}` + }, + }, + grid: { top: 88, right: 24, bottom: 44, left: 52 }, + xAxis: { type: 'value', name: 'cyQty', scale: true }, + yAxis: { type: 'value', name: 'AE 条数', scale: true }, + series: [{ type: 'scatter', symbolSize: 12, data }], + } +} + +const hospitalComplaintQtyScatterOption = (context: AnalysisContext): EChartsOption => { + const pts = buildHospitalComplaintVsAdmissionQty(context) + const data = pts.map((p) => [p.cyQty, p.complaints, p.hospital]) + return { + title: { + text: '医院：投诉条数 vs 入院 cyQty', + subtext: QLT_TIME_AXIS, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { + formatter: (params: unknown) => { + const p = params as { value?: [number, number, string] } + const v = p.value + if (!v) return '' + return `${v[2]}
cyQty：${v[0]}
投诉：${v[1]}` + }, + }, + grid: { top: 88, right: 24, bottom: 44, left: 52 }, + xAxis: { type: 'value', name: 'cyQty', scale: true }, + yAxis: { type: 'value', name: '投诉条数', scale: true }, + series: [{ type: 'scatter', symbolSize: 12, data }], + } +} + +const productHalfYearBarOption = (context: AnalysisContext): EChartsOption => { + const h1 = new Map() + const h2 = new Map() + for (const c of context.complaints) { + const mo = Number.parseInt(c.registerDate.slice(5, 7), 10) + const p = c.productName + if (mo <= 6) h1.set(p, (h1.get(p) ?? 0) + 1) + else h2.set(p, (h2.get(p) ?? 0) + 1) + } + const products = [...new Set([...h1.keys(), ...h2.keys()])].sort() + return { + title: { + text: '产品投诉量：上半年 vs 下半年', + subtext: 'C3登记月份 1–6 vs 7–12｜QLT-TRN-703 对比窗演示', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + legend: { top: 72 }, + grid: { top: 100, right: 24, bottom: 56, left: 44 }, + xAxis: { type: 'category', data: products, axisLabel: { rotate: 22 } }, + yAxis: { type: 'value', name: '投诉条数' }, + series: [ + { name: '上半年(1–6月)', type: 'bar', data: products.map((p) => h1.get(p) ?? 0) }, + { name: '下半年(7–12月)', type: 'bar', data: products.map((p) => h2.get(p) ?? 0) }, + ], + } +} + +const productGrowthAlertBarOption = (context: AnalysisContext): EChartsOption => { + const alertRows = buildProductComplaintHalfYearGrowth(context) + const h1 = new Map() + const h2 = new Map() + for (const c of context.complaints) { + const mo = Number.parseInt(c.registerDate.slice(5, 7), 10) + if (mo <= 6) h1.set(c.productName, (h1.get(c.productName) ?? 0) + 1) + else h2.set(c.productName, (h2.get(c.productName) ?? 0) + 1) + } + const labels = alertRows.length + ? alertRows.map((r) => r.product) + : [...new Set(context.complaints.map((c) => c.productName))].sort() + return { + title: { + text: '产品投诉增速预警（下半年相对上半年 ≥20%）', + subtext: alertRows.length ? 'QLT-TRN-703' : 'QLT-TRN-703｜当前样本无达阈产品，展示全产品上下半年对照', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + legend: { top: 72 }, + grid: { top: 100, right: 24, bottom: 56, left: 44 }, + xAxis: { type: 'category', data: labels, axisLabel: { rotate: 22 } }, + yAxis: { type: 'value', name: '投诉条数' }, + series: [ + { name: '上半年', type: 'bar', data: labels.map((p) => h1.get(p) ?? 0) }, + { name: '下半年', type: 'bar', data: labels.map((p) => h2.get(p) ?? 0) }, + ], + } +} + +const provinceHalfYearBarOption = (context: AnalysisContext): EChartsOption => { + const rows = buildProvinceComplaintHalfYearGrowth(context) + const labels = rows.map((r) => r.province) + return { + title: { + text: '省份投诉量：上半年 vs 下半年', + subtext: '医院→省映射取自入院量表众数｜QLT-TRN-704', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + legend: { top: 72 }, + grid: { top: 100, right: 24, bottom: 48, left: 44 }, + xAxis: { type: 'category', data: labels }, + yAxis: { type: 'value', name: '投诉条数' }, + series: [ + { name: '上半年', type: 'bar', data: rows.map((r) => r.firstHalf) }, + { name: '下半年', type: 'bar', data: rows.map((r) => r.secondHalf) }, + ], + } +} + +const complaintRateBarOption = (context: AnalysisContext): EChartsOption => { + const rows = buildHospitalProductComplaintRate(context).slice(0, 10) + const labels = rows.map((r) => `${r.hospital} / ${r.product}`) + return { + title: { + text: '医院×产品 投诉率 Top（每千件入院量）', + subtext: `QLT-SAL-901｜${QLT_ADMISSION_DENOM}`, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: 88, right: 24, bottom: 8, left: 8, containLabel: true }, + xAxis: { type: 'value', name: '件/千件' }, + yAxis: { type: 'category', data: labels, axisLabel: { fontSize: 10 } }, + series: [{ type: 'bar', data: rows.map((r) => r.ratePer1000), itemStyle: { borderRadius: [0, 4, 4, 0] } }], + } +} + +const isAeRateBarOption = (context: AnalysisContext): EChartsOption => { + const rows = buildIsAeRateByProduct(context) + return { + title: { + text: '按产品的投诉升级率（是否不良事件=是）', + subtext: 'QLT-AE-1001', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: 72, right: 24, bottom: 48, left: 44 }, + xAxis: { type: 'category', data: rows.map((r) => r.product), axisLabel: { rotate: 18 } }, + yAxis: { type: 'value', name: '%', max: 100 }, + series: [{ type: 'bar', data: rows.map((r) => r.ratePct), itemStyle: { borderRadius: [4, 4, 0, 0] } }], + } +} + +const investigationPieOption = (context: AnalysisContext): EChartsOption => { + const dist = buildInvestigationConclusionDist(context) + return { + title: { + text: '调查结论分布', + subtext: 'QLT-INV-501', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'item' }, + series: [ + { + type: 'pie', + radius: ['34%', '60%'], + label: { formatter: '{b}: {c} ({d}%)' }, + data: dist.map(([name, value]) => ({ name, value })), + }, + ], + } +} + +const compensationPieOption = (context: AnalysisContext): EChartsOption => { + const dist = buildCompensationDist(context) + return { + title: { + text: '赔付结论分布', + subtext: 'QLT-CST-601', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'item' }, + series: [ + { + type: 'pie', + radius: ['34%', '60%'], + label: { formatter: '{b}: {c} ({d}%)' }, + data: dist.map(([name, value]) => ({ name, value })), + }, + ], + } +} + +const defectProductFaultBarOption = (context: AnalysisContext): EChartsOption => { + const d = buildDefectConfirmedProductFault(context) + return barOption('产品缺陷成立：产品×故障 Top', d.labels, d.values, 'QLT-INV-502') +} + +const batchComplaintAeBarOption = (context: AnalysisContext): EChartsOption => { + const rows = buildBatchComplaintVsAeCounts(context).filter((r) => r.complaints + r.aeReports > 0) + return { + title: { + text: '批号：投诉条数 vs AE 条数', + subtext: 'QLT-BTH-104｜同批号字符串对照（非逐条匹配）', + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + legend: { top: 72 }, + grid: { top: 100, right: 24, bottom: 48, left: 44 }, + xAxis: { type: 'category', data: rows.map((r) => r.batchNo), axisLabel: { rotate: 18 } }, + yAxis: { type: 'value', name: '条数' }, + series: [ + { name: '投诉', type: 'bar', data: rows.map((r) => r.complaints) }, + { name: 'AE', type: 'bar', data: rows.map((r) => r.aeReports) }, + ], + } +} + +const complaintMonthlyLineOption = (context: AnalysisContext): EChartsOption => { + const t = buildComplaintMonthly(context) + return lineOption('投诉月度趋势（C3登记月）', t.months, t.values, '投诉条数', `${QUALITY_DOC_REF}｜QLT 时间轴`) +} + +const marketingHBarOption = ( + title: string, + subtext: string, + labels: string[], + values: number[], + xAxisName: string, +): EChartsOption => ({ + title: { + text: title, + subtext, + left: 'center', + textStyle: { fontSize: 14 }, + subtextStyle: { fontSize: 11, color: '#64748b' }, + }, + tooltip: { trigger: 'axis' }, + grid: { top: 88, right: 28, bottom: 12, left: 12, containLabel: true }, + xAxis: { type: 'value', name: xAxisName }, + yAxis: { type: 'category', data: labels, axisLabel: { fontSize: 10 } }, + series: [{ type: 'bar', data: values, itemStyle: { borderRadius: [0, 4, 4, 0] } }], +}) + +const mktOpWrongHospitalOption = (context: AnalysisContext): EChartsOption => { + const d = buildOpWrongHospitalTop(context, 14) + return barOption('操作不当投诉：医院 Top', d.labels, d.values, 'MKT-OP-101') +} + +const mktOpWrongDealerCountOption = (context: AnalysisContext): EChartsOption => { + const d = buildOpWrongDealerCounts(context, 14) + return barOption('操作不当投诉：经销商（条数）', d.labels, d.values, 'MKT-OP-102') +} + +const mktDealerOpWrongRateOption = (context: AnalysisContext): EChartsOption => { + const d = buildDealerOpWrongRatePer1000(context, 14) + return marketingHBarOption( + '经销商操作不当率（件/千件入院量）', + `MKT-OP-103｜${MARKETING_DOC_REF}`, + d.labels, + d.values, + '件/千件', + ) +} + +const mktProductOpWrongShareOption = (context: AnalysisContext): EChartsOption => { + const d = buildProductOpWrongSharePct(context, 12) + return marketingHBarOption( + '产品：操作不当占该产品投诉比例（%）', + 'MKT-OP-104｜子集=调查结论为「操作不当」', + d.labels, + d.values, + '%', + ) +} + +const mktProvinceComplaintRateOption = (context: AnalysisContext): EChartsOption => { + const d = buildProvinceComplaintRatePer1000(context, 16) + return marketingHBarOption( + '省级投诉率（件/千件入院量）', + `MKT-RG-201｜${MKT_ADMISSION_DENOM}`, + d.labels, + d.values, + '件/千件', + ) +} + +const mktDealerComplaintRateOption = (context: AnalysisContext): EChartsOption => { + const d = buildDealerComplaintRatePer1000(context, 16) + return marketingHBarOption( + '经销商投诉率（件/千件入院量）', + `MKT-RG-202｜${MARKETING_DOC_REF}`, + d.labels, + d.values, + '件/千件', + ) +} + +const mktProvinceComplaintCountOption = (context: AnalysisContext): EChartsOption => { + const d = buildProvinceComplaintCounts(context, 14) + return barOption('省级投诉条数 Top（绝对量）', d.labels, d.values, 'MKT-RG-203') +} + +const configs: Record = { + 'compliance-psur': { + key: 'compliance-psur', + title: 'PSUR 监管分析', + pillar: 'monitor', + strategyRef: '合规方向分析 §2', + subtitle: '监测层：按《合规方向分析》CMP-AE-101/201/301/401/501/601/701 等演示实现。', + sections: [ + { + id: 'psur-trend', + title: '总体趋势与暴露', + strategyRefs: ['CMP-AE-101', 'CMP-AE-201', 'CMP-AE-301'], + charts: [ + { + id: 'psur-monthly', + title: '不良事件月度趋势（按发生日期）', + description: COMPLIANCE_FOOTNOTE_SHORT, + chartExplain: ex( + '不良事件表；时间过滤=发生日期 occurrenceDate；统计单元=每条 AE 记录计 1。', + 'CMP-AE-101：按公历月对报告条数求和，用于 PSUR「总体趋势」与异常上升监测。', + ), + optionBuilder: (context) => { + const trend = buildAeMonthlyByOccurrence(context) + return lineOption( + 'CMP-AE-101 不良事件报告数', + trend.months, + trend.values, + '事件数', + `${COMPLIANCE_DOC_REF}｜主时间轴=发生日期｜单元=报告条数`, + ) + }, + }, + { + id: 'psur-ppm', + title: '全局月度 PPM（入院量 cyQty 分母）', + description: COMPLIANCE_FOOTNOTE_PPM, + chartExplain: ex( + '分子=AE 按发生月计数；分母=入院量表按业务年月汇总 cyQty（演示未按产品拆分全量暴露）。', + 'CMP-AE-201：PPM = AE数/入院量×1e6；分母为 0 时在序列中用 null 表示不可算。', + ), + optionBuilder: (context) => { + const ppm = buildGlobalMonthlyPpm(context) + return lineOption( + 'CMP-AE-201 演示 PPM', + ppm.months, + ppm.ppm, + 'PPM', + `${COMPLIANCE_DOC_REF}｜分母=入院量 cyQty 按年月汇总`, + ) + }, + }, + { + id: 'psur-device-top', + title: '器械故障表现 Top（占比）', + description: COMPLIANCE_FOOTNOTE_SHORT, + chartExplain: ex( + '不良事件表 deviceFailure 字段；全量计数。', + 'CMP-AE-301：按故障表现归类计数取 Top；tooltip 可扩展占比=该类条数/当期 AE 总数。', + ), + optionBuilder: (context) => { + const top = buildTopDeviceFailures(context, 10) + return barOption( + 'CMP-AE-301 器械故障 Top', + top.labels, + top.values, + '条数=报告条数；占比见 tooltip', + ) + }, + }, + { + id: 'psur-product-top', + title: '产品事件 Top 分布', + description: COMPLIANCE_FOOTNOTE_SHORT, + chartExplain: ex('不良事件表 productName 全量。', '按产品聚合 AE 报告条数取 Top，用于 PSUR 产品章节与管理驾驶舱分产品线视图。'), + optionBuilder: (context) => { + const top = buildPsurTopProducts(context) + return barOption('产品 AE 条数 Top', top.labels, top.values, COMPLIANCE_DOC_REF) + }, + }, + ], + }, + { + id: 'psur-serious', + title: '严重事件、区域与上报时效', + strategyRefs: ['CMP-AE-501', 'CMP-AE-502', 'CMP-AE-601', 'CMP-AE-701'], + charts: [ + { + id: 'psur-sae-monthly', + title: 'SAE 报告数（按发生月）', + description: 'SAE：死亡/危及生命/残疾/住院或延长住院 任一（演示字段）', + chartExplain: ex( + '不良事件表；SAE 子集由四个布尔字段任一为真判定（与合规方向分析 §1.4 一致）。', + 'CMP-AE-501：在 SAE 子集上按发生月计数，用于严重事件专章趋势。', + ), + optionBuilder: (context) => { + const s = buildSaeMonthlyByOccurrence(context) + return lineOption('CMP-AE-501 SAE 条数', s.months, s.values, 'SAE 条数', COMPLIANCE_DOC_REF) + }, + }, + { + id: 'psur-sae-share', + title: 'SAE 占全部 AE 比例（按发生月）', + description: 'CMP-AE-502', + chartExplain: ex('同月内 SAE 条数与全部 AE 条数之比，时间轴=发生月。', 'CMP-AE-502：观察严重事件是否在总量上升同时占比上升。'), + optionBuilder: (context) => { + const s = buildSaeShareMonthly(context) + return lineOption('CMP-AE-502 SAE%', s.months, s.shares, '占比%', COMPLIANCE_DOC_REF) + }, + }, + { + id: 'psur-province', + title: '省级 AE 报告数', + description: 'CMP-AE-601', + chartExplain: ex('不良事件表 province 字段；全期按省聚合。', 'CMP-AE-601：省级报告条数分布，用于地理聚集识别（地图可视化可后续接入）。'), + optionBuilder: (context) => { + const p = buildProvinceAeCounts(context) + return barOption('CMP-AE-601 省分布', p.labels, p.values, COMPLIANCE_DOC_REF) + }, + }, + { + id: 'psur-lag-histogram', + title: '上报滞后天数分布', + description: 'Lag = 审核日期 − 登记日期｜CMP-AE-701', + chartExplain: ex( + 'AE 表 reviewDate、registrationDate 均可解析的行；Lag=审核日期−登记日期（天）。', + 'CMP-AE-701：对滞后天数做直方分箱，支撑上报时效分布与内控阈值讨论。', + ), + optionBuilder: reportingLagHistogramOption, + }, + ], + }, + ], + }, + 'compliance-audit': { + key: 'compliance-audit', + title: '上报合规性审计', + pillar: 'diagnose', + strategyRef: '合规方向分析 §3', + subtitle: '诊断层：CMP-CV-101~104 与 CMP-AE-701/702 双口径演示。', + sections: [ + { + id: 'audit-core', + title: '审计核心指标', + strategyRefs: ['CMP-CV-101', 'CMP-CV-104', 'CMP-AE-702'], + charts: [ + { + id: 'audit-summary-bar', + title: '漏报 / 匹配 / 时效（双口径）', + description: COMPLIANCE_FOOTNOTE_AUDIT, + chartExplain: ex( + '基准=投诉 isAe=true；匹配规则=医院+产品+型号一致且 AE 发生日与 C3登记日相差≤30天。', + '汇总漏报率、匹配率及匹配子集上「审核−登记」「审核−C3」≤15 天占比（演示阈值）。', + ), + optionBuilder: complianceAuditSummaryOption, + }, + { + id: 'audit-counts-pie', + title: '应报样本结构', + description: '投诉 isAe=是', + chartExplain: ex( + '同上基准集合；在可匹配与疑似漏报二分结构上展示样本量。', + '饼图用于审计抽样框说明：已匹配 vs 需人工复核的疑似漏报。', + ), + optionBuilder: complianceAuditCountsOption, + }, + ], + }, + ], + }, + 'quality-concentration': { + key: 'quality-concentration', + title: '投诉集中性与 Pareto', + pillar: 'diagnose', + strategyRef: '质量方向分析 §2–§3', + subtitle: '诊断层：QLT-PRD-401 / QLT-BTH-101 / QLT-CNC 系列（集中性）。', + sections: [ + { + id: 'quality-pareto', + title: '集中性与批号', + strategyRefs: ['QLT-PRD-401', 'QLT-BTH-101', 'QLT-CNC-301~303'], + charts: [ + { + id: 'quality-pareto-chart', + title: '产品×故障 Pareto（二八）', + description: 'QLT-PRD-401', + chartExplain: ex( + `质量投诉表；${QLT_TIME_AXIS}；取 Top8 产品×故障组合。`, + '对「产品名称×故障类型」计数并降序；同时给出累计占比曲线，用于识别贡献约 80% 投诉的组合（Pareto）。', + ), + optionBuilder: paretoOption, + }, + { + id: 'quality-batch-chart', + title: '批号投诉条数排名', + description: 'QLT-BTH-101', + chartExplain: ex( + '质量投诉表 batchNo 字段；空批号归入「（未填批号）」桶。', + '在统计期内按批号分组对投诉条数计数并取 Top，用于触发批次调查（问题批次识别）。', + ), + optionBuilder: (context) => { + const batch = buildComplaintBatchTop(context, 8) + return barOption('批号投诉 Top', batch.labels, batch.values, QUALITY_DOC_REF) + }, + }, + { + id: 'quality-hospital-top', + title: '医院投诉条数 Top', + description: 'QLT-CNC-301', + chartExplain: ex( + '质量投诉表；按医院名称聚合。', + '统计各医院投诉条数并取 Top，用于识别投诉集中医院（现场调查/培训优先级）。', + ), + optionBuilder: (context) => { + const t = buildTopHospitalsComplaints(context, 8) + return barOption('医院投诉 Top', t.labels, t.values, QUALITY_DOC_REF) + }, + }, + { + id: 'quality-product-fault-top', + title: '故障类型 Top', + description: 'QLT-CNC-303', + chartExplain: ex('质量投诉表 faultType 字段。', '按故障类型计数取 Top，与 Pareto 组合图互补的一维缺陷雷达。'), + optionBuilder: (context) => { + const t = buildTopFaultTypes(context, 8) + return barOption('故障类型 Top', t.labels, t.values, QUALITY_DOC_REF) + }, + }, + ], + }, + ], + }, + 'quality-trends': { + key: 'quality-trends', + title: '趋势分析', + pillar: 'monitor', + strategyRef: '质量方向分析 §2.2 / §4.1', + subtitle: '监测层：月度趋势与上下半年对比、区域对比（QLT-TRN-703/704）。', + sections: [ + { + id: 'trend-core', + title: '时间与对比窗', + strategyRefs: ['QLT-TRN-703', 'QLT-TRN-704'], + charts: [ + { + id: 'trend-monthly', + title: '投诉月度趋势', + description: 'C3登记月', + chartExplain: ex( + `质量投诉表；${QLT_TIME_AXIS}；按公历年月桶聚合。`, + '对每个自然月统计投诉条数，观察总量是否异常上升（与主策略 §3.2 趋势主题一致）。', + ), + optionBuilder: complaintMonthlyLineOption, + }, + { + id: 'trend-product-half', + title: '产品：上/下半年投诉量', + description: 'QLT-TRN-703', + chartExplain: ex( + '质量投诉表；以登记日期的月份区分上半年(1–6)与下半年(7–12)。', + '按产品对两个半年窗口分别计数，用于与增速预警表对照阅读。', + ), + optionBuilder: productHalfYearBarOption, + }, + { + id: 'trend-product-alert', + title: '产品投诉增速预警', + description: 'QLT-TRN-703', + chartExplain: ex( + '同上、对比窗为同一公历年的上下半年。', + '当 (下半年−上半年)/上半年 ≥ 20%（且上半年>0）或「上半年零且下半年≥2」时纳入预警柱图。', + ), + optionBuilder: productGrowthAlertBarOption, + }, + { + id: 'trend-province-half', + title: '省份：上/下半年投诉量', + description: 'QLT-TRN-704', + chartExplain: ex( + '投诉侧按医院映射至省份：映射表由入院量数据中「医院→省」出现频次众数生成。', + '将投诉按登记月拆上下半年，在省级桶内计数，用于区域波动监测。', + ), + optionBuilder: provinceHalfYearBarOption, + }, + ], + }, + ], + }, + 'quality-complaint-sales': { + key: 'quality-complaint-sales', + title: '投诉行为：销售与入院关联', + pillar: 'diagnose', + strategyRef: '质量方向分析 §4.3', + subtitle: '诊断层：投诉量与入院量关系、医院×产品投诉率（QLT-SAL-901）。', + sections: [ + { + id: 'qc-sales', + title: '入院与投诉率', + strategyRefs: ['QLT-SAL-901', '主策略 3.3 a'], + charts: [ + { + id: 'qc-sales-scatter', + title: '医院：投诉条数 vs 入院 cyQty', + description: '散点', + chartExplain: ex( + '投诉按医院计数；入院量表按 HospitalName 汇总 cyQty（跨月相加，演示口径）。', + '用于观察「入院量大是否必然投诉多」；偏离对角带可为异常医院信号（需结合床位/产品结构）。', + ), + optionBuilder: hospitalComplaintQtyScatterOption, + }, + { + id: 'qc-sales-rate', + title: '医院×产品 投诉率 Top（每千件）', + description: 'QLT-SAL-901', + chartExplain: ex( + `分子=统计期内医院+产品投诉条数；分母=入院量表同键 cyQty 汇总。${QLT_ADMISSION_DENOM}。`, + '投诉率 = 投诉条数 / cyQty × 1000；取 Top10 横向条形图，突出相对暴露下的高频组合。', + ), + optionBuilder: complaintRateBarOption, + }, + ], + }, + ], + }, + 'quality-complaint-investigation': { + key: 'quality-complaint-investigation', + title: '投诉行为：调查与赔付关系', + pillar: 'act', + strategyRef: '质量方向分析 §3.3–§3.4', + subtitle: '决策层：调查结论池、缺陷成立组合、赔付结构（QLT-INV / QLT-CST）。', + sections: [ + { + id: 'qc-investigation', + title: '调查与成本', + strategyRefs: ['QLT-INV-501', 'QLT-INV-502', 'QLT-CST-601'], + charts: [ + { + id: 'qc-inv-pie', + title: '调查结论分布', + description: 'QLT-INV-501', + chartExplain: ex( + '质量投诉表 conclusion（调查结论）字段全量有效行。', + '对结论类别计数并计算占比，观察「产品缺陷成立」等结构是否恶化。', + ), + optionBuilder: investigationPieOption, + }, + { + id: 'qc-defect-bar', + title: '产品缺陷成立：产品×故障 Top', + description: 'QLT-INV-502', + chartExplain: ex( + '子集：调查结论=「产品缺陷成立」的投诉记录。', + '在子集内按「产品×故障」计数排序，形成已确认质量问题池，供 CAPA/设计变更引用。', + ), + optionBuilder: defectProductFaultBarOption, + }, + { + id: 'qc-comp-pie', + title: '赔付结论分布', + description: 'QLT-CST-601', + chartExplain: ex('质量投诉表 compensation（赔付结论）字段。', '统计各类赔付方式占比，作为质量失败外显成本（COQ）结构的入口指标。'), + optionBuilder: compensationPieOption, + }, + { + id: 'qc-product-top', + title: '产品投诉条数 Top', + description: 'QLT-CNC-302', + chartExplain: ex('质量投诉表 productName。', '按产品聚合投诉条数，与调查/赔付饼图联读以定位重点产品。'), + optionBuilder: (context) => { + const t = buildTopProductsComplaints(context, 8) + return barOption('产品投诉 Top', t.labels, t.values, QUALITY_DOC_REF) + }, + }, + ], + }, + ], + }, + 'quality-complaint-batch': { + key: 'quality-complaint-batch', + title: '投诉行为：批次与稳定性', + pillar: 'diagnose', + strategyRef: '质量方向分析 §2', + subtitle: '诊断层：批号与 AE 双通道对照、关闭周期（QLT-BTH-104 / QLT-RPT-802）。', + sections: [ + { + id: 'qc-batch', + title: '批次与闭环', + strategyRefs: ['QLT-BTH-104', 'QLT-RPT-802'], + charts: [ + { + id: 'qc-batch-ae', + title: '批号：投诉 vs AE 条数', + description: 'QLT-BTH-104', + chartExplain: ex( + '投诉侧 batchNo；AE 侧 productBatch（batchNo）；剔除双方均为 0 的批号。', + '同一批号字符串在投诉表 batchNo 与 AE 表 batchNo 上分别计数，用于市场反馈与监管报告双通道对照（非逐条匹配）。', + ), + optionBuilder: batchComplaintAeBarOption, + }, + { + id: 'qc-close-cycle', + title: '投诉关闭周期分布', + description: 'QLT-RPT-802', + chartExplain: ex( + '仅统计 closeDate、registerDate 均可解析且差分≥0 的投诉行。', + '关闭周期=关闭日期−C3登记日期，按天分段聚合为直方图，用于流程效率与结案 SLA 讨论。', + ), + optionBuilder: closeCycleHistogramOption, + }, + ], + }, + ], + }, + 'quality-complaint-text': { + key: 'quality-complaint-text', + title: '投诉行为：文本与流程类', + pillar: 'goal', + strategyRef: '3.3 p-x', + subtitle: '目标层，占位展示文本挖掘与流程效率方向。', + sections: [{ id: 'qc-text', title: '主题组 D', strategyRefs: ['3.3 p-x'], charts: [...placeholderPair('qc-text-a'), ...placeholderPair('qc-text-b')] }], + }, + 'quality-ae-cause': { + key: 'quality-ae-cause', + title: 'AE 报告原因推测', + pillar: 'diagnose', + strategyRef: '质量方向分析 §4.4', + subtitle: '诊断层：AE 与入院量散点、按产品升级率（QLT-AE-1001/1003）。', + sections: [ + { + id: 'ae-cause', + title: '报告行为与升级', + strategyRefs: ['QLT-AE-1003', 'QLT-AE-1001'], + charts: [ + { + id: 'ae-scatter-hosp', + title: '医院：AE 条数 vs 入院 cyQty', + description: 'QLT-AE-1003', + chartExplain: ex( + 'AE 表按 unitName 计数报告条数；入院表按 HospitalName 汇总 cyQty；AE 未按投诉时间轴过滤。', + '用于发现「相对入院量异常高报告」的医院点；解读需结合合规口径（发生日期）与报告动机，不等同于质量差。', + ), + optionBuilder: hospitalAeScatterOption, + }, + { + id: 'ae-upgrade-rate', + title: '按产品的投诉升级率', + description: 'QLT-AE-1001', + chartExplain: ex( + '质量投诉表 isAe（是否不良事件）与 productName。', + '升级率 = 该产品 isAe=true 的投诉条数 / 该产品总投诉条数 ×100%，比较各产品线升级意愿差异。', + ), + optionBuilder: isAeRateBarOption, + }, + ], + }, + ], + }, + 'quality-ae-only': { + key: 'quality-ae-only', + title: '报告不投诉分析', + pillar: 'monitor', + strategyRef: '3.4.2', + subtitle: '监测层：AE 器械故障分布（演示）。', + sections: [ + { + id: 'ae-only', + title: '仅 AE 报告', + strategyRefs: ['3.4.2'], + charts: [ + { + id: 'ae-only-failure', + title: 'AE 器械故障表现分布', + description: '演示', + chartExplain: ex( + '不良事件表全量；字段 deviceFailure。', + '对仅走监管通道的报告，按器械故障表现聚类，辅助理解「未并发投诉」的事件形态（主策略 §3.4.2 占位深化方向）。', + ), + optionBuilder: (context) => { + const top = buildTopDeviceFailures(context, 8) + return barOption('AE 故障 Top', top.labels, top.values, COMPLIANCE_DOC_REF) + }, + }, + { + id: 'ae-only-monthly', + title: 'AE 月度条数（发生日期）', + description: '演示', + chartExplain: ex('不良事件表 occurrenceDate 按月桶。', '与投诉月度趋势对照时须在业务上区分两条时间轴。'), + optionBuilder: (context) => { + const t = buildAeMonthlyByOccurrence(context) + return lineOption('AE 月度', t.months, t.values, 'AE 条数', COMPLIANCE_DOC_REF) + }, + }, + ], + }, + ], + }, + 'quality-ae-with-complaint': { + key: 'quality-ae-with-complaint', + title: '报告且投诉分析', + pillar: 'diagnose', + strategyRef: '3.4.3', + subtitle: '诊断层：已升级投诉（isAe=true）的故障类型分布（演示）。', + sections: [ + { + id: 'ae-with-complaint', + title: '报告+投诉交集', + strategyRefs: ['3.4.3'], + charts: [ + { + id: 'ae-with-fault', + title: '已升级投诉的故障类型分布', + description: 'isAe=true', + chartExplain: ex( + '子集：质量投诉表 isAe=true。', + '在「已升级」子集上按 faultType 计数，用于与 AE 表伤害/故障矩阵叙事衔接（细粒度匹配规则见合规审计主题）。', + ), + optionBuilder: (context) => { + const sub = context.complaints.filter((c) => c.isAe) + const m = new Map() + sub.forEach((c) => m.set(c.faultType, (m.get(c.faultType) ?? 0) + 1)) + const sorted = [...m.entries()].sort((a, b) => b[1] - a[1]) + return barOption( + '升级投诉故障类型', + sorted.map((i) => i[0]), + sorted.map((i) => i[1]), + QUALITY_DOC_REF, + ) + }, + }, + { + id: 'ae-with-monthly', + title: '已升级投诉的登记月份趋势', + description: 'C3登记月', + chartExplain: ex('子集：isAe=true；时间字段 registerDate。', '观察升级投诉在登记时间上的分布，用于与 AE 发生月趋势对照。'), + optionBuilder: (context) => { + const sub = context.complaints.filter((c) => c.isAe) + const counter = new Map() + sub.forEach((c) => { + const k = c.registerDate.slice(0, 7) + counter.set(k, (counter.get(k) ?? 0) + 1) + }) + const months = [...counter.keys()].sort() + return lineOption('升级投诉月度', months, months.map((x) => counter.get(x) ?? 0), '条数', QUALITY_DOC_REF) + }, + }, + ], + }, + ], + }, + 'marketing-operation-training': { + key: 'marketing-operation-training', + title: '操作不当与培训', + pillar: 'act', + strategyRef: '营销方向分析 §2', + subtitle: '决策层：MKT-OP-101~104，支撑医院清单、经销商辅导与培训素材优先级。', + sections: [ + { + id: 'marketing-operation', + title: '培训与使用支持', + strategyRefs: ['MKT-OP-101', 'MKT-OP-102', 'MKT-OP-103', 'MKT-OP-104'], + charts: [ + { + id: 'mkt-op-hospital', + title: '操作不当投诉：医院分布', + description: 'MKT-OP-101', + chartExplain: ex( + `投诉表子集：调查结论=「操作不当」；${MKT_TIME_AXIS}；全量 mock。`, + '按医院名称计数操作不当投诉条数并取 Top，用于院内培训与跟台优先级（主策略 §4.1）。', + ), + optionBuilder: mktOpWrongHospitalOption, + }, + { + id: 'mkt-op-dealer-count', + title: '操作不当投诉：经销商条数', + description: 'MKT-OP-102', + chartExplain: ex( + `同上子集；${MKT_HOSPITAL_MAP} 将投诉归入经销商后计数。`, + '识别操作不当投诉绝对量高的经销商，作为渠道侧约谈与联合巡院名单输入。', + ), + optionBuilder: mktOpWrongDealerCountOption, + }, + { + id: 'mkt-op-dealer-rate', + title: '经销商操作不当率（入院量分母）', + description: 'MKT-OP-103', + chartExplain: ex( + `分子=各经销商子集内操作不当投诉条数；分母=入院量表同 DealerName 的 CY Qty 汇总；${MKT_ADMISSION_DENOM}。`, + '率=分子/分母×1000（件/千件），用于发现「相对销量操作不当偏多」的经销商（主策略 §4.1）。', + ), + optionBuilder: mktDealerOpWrongRateOption, + }, + { + id: 'mkt-op-product-share', + title: '产品：操作不当占比', + description: 'MKT-OP-104', + chartExplain: ex( + '全量投诉按产品计数分母；分子为该产品调查结论=操作不当的条数。', + '占比=操作不当条数/该产品投诉总条数×100%，用于说明书、操作视频与数字化推广素材的迭代优先级。', + ), + optionBuilder: mktProductOpWrongShareOption, + }, + ], + }, + ], + }, + 'marketing-region-dealer': { + key: 'marketing-region-dealer', + title: '区域与经销商投诉率', + pillar: 'monitor', + strategyRef: '营销方向分析 §3', + subtitle: '监测层：MKT-RG-201~203，区分相对率与绝对量。', + sections: [ + { + id: 'marketing-region', + title: '区域与渠道', + strategyRefs: ['MKT-RG-201', 'MKT-RG-202', 'MKT-RG-203'], + charts: [ + { + id: 'mkt-rg-province-rate', + title: '省级投诉率（件/千件入院量）', + description: 'MKT-RG-201', + chartExplain: ex( + `投诉经医院映射至省（${MKT_HOSPITAL_MAP}）；分母为入院量同省 CY Qty 汇总；${MKT_TIME_AXIS}。`, + '投诉率=投诉条数/入院量×1000，用于区域活动与资源排序（主策略 §4.2）。', + ), + optionBuilder: mktProvinceComplaintRateOption, + }, + { + id: 'mkt-rg-dealer-rate', + title: '经销商投诉率（件/千件入院量）', + description: 'MKT-RG-202', + chartExplain: ex( + `投诉经医院映射至经销商众数；分母为入院量表 DealerName 维度 CY Qty 汇总。`, + '用于渠道储运、覆盖密度与客户支持资源的再分配假设验证（主策略 §4.2）。', + ), + optionBuilder: mktDealerComplaintRateOption, + }, + { + id: 'mkt-rg-province-count', + title: '省级投诉条数 Top（绝对量）', + description: 'MKT-RG-203', + chartExplain: ex( + '全量投诉按省计数，不按入院量标准化。', + '与省级投诉率对照，区分「人口/销量大省带来的绝对量大」与「相对率异常高」。', + ), + optionBuilder: mktProvinceComplaintCountOption, + }, + ], + }, + ], + }, + 'substance-matrix': { + key: 'substance-matrix', + title: '伤害 × 故障矩阵', + pillar: 'diagnose', + strategyRef: '合规方向分析 §2.4 / 主策略 5.1', + subtitle: '诊断层：CMP-AE-401 全量与 CMP-AE-402 SAE 子集对照。', + sections: [ + { + id: 'substance-matrix', + title: '关联矩阵', + strategyRefs: ['CMP-AE-401', 'CMP-AE-402'], + charts: [ + { + id: 'matrix-all', + title: '伤害 × 器械故障（全量 AE）', + description: COMPLIANCE_FOOTNOTE_SHORT, + chartExplain: ex( + '不良事件表 injuryExpression × deviceFailure；时间过滤默认全量（可按发生日期窗扩展）。', + 'CMP-AE-401：二维计数矩阵，识别高频伤害-故障组合以支撑 CAPA 优先级。', + ), + optionBuilder: injuryDeviceHeatmapOption( + false, + 'CMP-AE-401 伤害-故障热力图', + `${COMPLIANCE_DOC_REF}｜按发生日期纳入全集`, + ), + }, + { + id: 'matrix-sae', + title: '伤害 × 器械故障（SAE 子集）', + description: 'CMP-AE-402', + chartExplain: ex( + '在 SAE 子集（四严重标准任一）上重复 CMP-AE-401 的矩阵统计。', + 'CMP-AE-402：聚焦严重结局组合模式，用于紧急医学评估与对外报告要点。', + ), + optionBuilder: injuryDeviceHeatmapOption( + true, + 'CMP-AE-402 SAE 子集', + '死亡/危及生命/残疾/住院或延长住院 任一', + ), + }, + ], + }, + ], + }, + 'substance-seasonality': { + key: 'substance-seasonality', + title: '故障季节性分析', + pillar: 'monitor', + strategyRef: '主策略 §5.2 / 质量方向分析 §5', + subtitle: '监测层：投诉侧「故障类型×登记月」热力图（与质量方向月度桶一致）。', + sections: [ + { + id: 'substance-seasonality', + title: '季节性模式', + strategyRefs: ['5.2', 'QLT-BTH-203'], + charts: [ + { + id: 'seasonality-heatmap', + title: '故障类型 × C3登记月', + description: '投诉热力', + chartExplain: ex( + '质量投诉表 faultType × registerDate 公历月份；全量 mock。', + '单元格=该月该故障类型的投诉条数；颜色越深投诉越多，用于观察高温/雨季等是否与某类故障同向波动（探索性，需外部气候数据佐证）。', + ), + optionBuilder: faultSeasonalityHeatmapOption, + }, + { + id: 'seasonality-monthly-total', + title: '投诉月度总量（对照）', + description: 'QLT 时间轴', + chartExplain: ex('质量投诉表 registerDate 按月聚合。', '给出各月投诉总量曲线，与热力图行合计一致，便于读趋势峰值月份。'), + optionBuilder: complaintMonthlyLineOption, + }, + ], + }, + ], + }, + 'portfolio-persona': { + key: 'portfolio-persona', + title: '安全维度客户画像', + pillar: 'goal', + strategyRef: '6', + subtitle: '目标层，占位展示高投诉高复购客户画像。', + sections: [{ id: 'portfolio-persona', title: '客户画像', strategyRefs: ['6'], charts: placeholderPair('portfolio-persona') }], + }, + 'portfolio-integrated': { + key: 'portfolio-integrated', + title: '综合联动分析', + pillar: 'act', + strategyRef: '7', + subtitle: '决策层，支撑监管风险热区与优先级矩阵。', + sections: [{ id: 'portfolio-integrated', title: '综合联动', strategyRefs: ['7'], charts: placeholderPair('portfolio-integrated') }], + }, +} + +export function getAnalysisDefinition(key: string): AnalysisPageDefinition | undefined { + return configs[key] +} diff --git a/analytics-demo-web/src/config/compliance-baseline.ts b/analytics-demo-web/src/config/compliance-baseline.ts new file mode 100644 index 0000000..0851e74 --- /dev/null +++ b/analytics-demo-web/src/config/compliance-baseline.ts @@ -0,0 +1,14 @@ +/** + * 与《分析策略/合规方向分析.md》§1.4 对齐的演示口径文案（用于页面脚注/图表说明）。 + * 演示数据为模拟；生产环境由配置中心或语义层下发。 + */ +export const COMPLIANCE_DOC_REF = '分析策略/合规方向分析.md §1.4' + +export const COMPLIANCE_FOOTNOTE_SHORT = + '主时间轴：发生日期｜单元：报告条数｜PPM 分母：入院量 cyQty｜获知：登记日期｜闭环：审核日期｜SAE：四类严重结局任一' + +export const COMPLIANCE_FOOTNOTE_PPM = + 'PPM = AE 报告条数÷同期入院量 cyQty×1e6；AE 按发生日期入桶，入院量按年月与产品汇总后与 AE 产品名对齐（演示）。' + +export const COMPLIANCE_FOOTNOTE_AUDIT = + '漏报：投诉「是否不良事件=是」在 ±30 天内无匹配 AE（医院+产品+型号，发生日期↔C3登记）；时效：Lag=审核日期−登记日期，演示阈值≤15 天。' diff --git a/analytics-demo-web/src/config/marketing-baseline.ts b/analytics-demo-web/src/config/marketing-baseline.ts new file mode 100644 index 0000000..7d681ac --- /dev/null +++ b/analytics-demo-web/src/config/marketing-baseline.ts @@ -0,0 +1,8 @@ +/** 与《分析策略/营销方向分析.md》口径对齐的 UI 脚注常量 */ +export const MARKETING_DOC_REF = '《营销方向分析》' + +export const MKT_TIME_AXIS = '投诉主时间轴=C3登记日期（registerDate）；统计单元=投诉条数' + +export const MKT_ADMISSION_DENOM = '入院量分母=入院表 CY Qty 在省或经销商维度汇总（演示与质量方向一致）' + +export const MKT_HOSPITAL_MAP = '医院→省/经销商：由入院量表按 HospitalName 对 Province、DealerName 取众数' diff --git a/analytics-demo-web/src/config/menu.ts b/analytics-demo-web/src/config/menu.ts new file mode 100644 index 0000000..13eb2c2 --- /dev/null +++ b/analytics-demo-web/src/config/menu.ts @@ -0,0 +1,240 @@ +import type { PillarType } from '../types/analysis' + +export interface MenuLeaf { + path: string + title: string + analysisKey: string + strategyRef: string + pillar: PillarType + /** 默认 AnalysisView；综合分析 / 问答为独立页面 */ + view?: 'comprehensive' | 'qa' +} + +export interface MenuGroup { + title: string + children: MenuLeaf[] +} + +export interface MenuSection { + title: string + basePath: string + children: MenuGroup[] +} + +export const menuSections: MenuSection[] = [ + { + title: '问答', + basePath: '/qa', + children: [ + { + title: '数据问答', + children: [ + { + path: '/qa/chat', + title: '智能问答', + analysisKey: 'qa-chat', + strategyRef: 'Demo 问答', + pillar: 'goal', + view: 'qa', + }, + ], + }, + ], + }, + { + title: '合规方向', + basePath: '/compliance', + children: [ + { + title: '监管报告', + children: [ + { + path: '/compliance/psur', + title: 'PSUR 监管分析', + analysisKey: 'compliance-psur', + strategyRef: '合规方向分析 §2', + pillar: 'monitor', + }, + { + path: '/compliance/audit', + title: '上报合规性审计', + analysisKey: 'compliance-audit', + strategyRef: '合规方向分析 §3', + pillar: 'diagnose', + }, + ], + }, + ], + }, + { + title: '质量方向', + basePath: '/quality', + children: [ + { + title: '核心分析', + children: [ + { + path: '/quality/concentration', + title: '投诉集中性与 Pareto', + analysisKey: 'quality-concentration', + strategyRef: '3.1', + pillar: 'diagnose', + }, + { + path: '/quality/trends', + title: '趋势分析', + analysisKey: 'quality-trends', + strategyRef: '3.2', + pillar: 'monitor', + }, + ], + }, + { + title: '投诉行为聚类', + children: [ + { + path: '/quality/complaint-sales', + title: '销售与入院关联', + analysisKey: 'quality-complaint-sales', + strategyRef: '3.3 a-c', + pillar: 'diagnose', + }, + { + path: '/quality/complaint-investigation', + title: '调查与赔付关系', + analysisKey: 'quality-complaint-investigation', + strategyRef: '3.3 e-f', + pillar: 'act', + }, + { + path: '/quality/complaint-batch', + title: '批次与稳定性', + analysisKey: 'quality-complaint-batch', + strategyRef: '3.3 g-o', + pillar: 'diagnose', + }, + { + path: '/quality/complaint-text', + title: '文本与流程类', + analysisKey: 'quality-complaint-text', + strategyRef: '3.3 p-x', + pillar: 'goal', + }, + ], + }, + { + title: 'AE 报告行为', + children: [ + { + path: '/quality/ae-cause', + title: 'AE 报告原因推测', + analysisKey: 'quality-ae-cause', + strategyRef: '3.4.1', + pillar: 'diagnose', + }, + { + path: '/quality/ae-only', + title: '报告不投诉分析', + analysisKey: 'quality-ae-only', + strategyRef: '3.4.2', + pillar: 'monitor', + }, + { + path: '/quality/ae-with-complaint', + title: '报告且投诉分析', + analysisKey: 'quality-ae-with-complaint', + strategyRef: '3.4.3', + pillar: 'diagnose', + }, + ], + }, + ], + }, + { + title: '营销方向', + basePath: '/marketing', + children: [ + { + title: '渠道与培训', + children: [ + { + path: '/marketing/operation-training', + title: '操作不当与培训', + analysisKey: 'marketing-operation-training', + strategyRef: '营销方向分析 §2', + pillar: 'act', + }, + { + path: '/marketing/region-dealer', + title: '区域与经销商投诉率', + analysisKey: 'marketing-region-dealer', + strategyRef: '营销方向分析 §3', + pillar: 'monitor', + }, + ], + }, + ], + }, + { + title: '事件实质', + basePath: '/substance', + children: [ + { + title: '风险本体', + children: [ + { + path: '/substance/matrix', + title: '伤害 × 故障矩阵', + analysisKey: 'substance-matrix', + strategyRef: '合规方向分析 §2.4', + pillar: 'diagnose', + }, + { + path: '/substance/seasonality', + title: '故障季节性分析', + analysisKey: 'substance-seasonality', + strategyRef: '5.2', + pillar: 'monitor', + }, + ], + }, + ], + }, + { + title: '画像与综合', + basePath: '/portfolio', + children: [ + { + title: '综合洞察', + children: [ + { + path: '/portfolio/comprehensive', + title: '综合分析', + analysisKey: 'portfolio-comprehensive', + strategyRef: '综合分析.md', + pillar: 'goal', + view: 'comprehensive', + }, + { + path: '/portfolio/persona', + title: '安全维度客户画像', + analysisKey: 'portfolio-persona', + strategyRef: '6', + pillar: 'goal', + }, + { + path: '/portfolio/integrated', + title: '综合联动分析', + analysisKey: 'portfolio-integrated', + strategyRef: '7', + pillar: 'act', + }, + ], + }, + ], + }, +] + +export const allLeaves = menuSections.flatMap((section) => + section.children.flatMap((group) => group.children), +) diff --git a/analytics-demo-web/src/config/quality-baseline.ts b/analytics-demo-web/src/config/quality-baseline.ts new file mode 100644 index 0000000..ffe09e3 --- /dev/null +++ b/analytics-demo-web/src/config/quality-baseline.ts @@ -0,0 +1,6 @@ +/** 与《分析策略/质量方向分析.md》口径对齐的 UI 脚注常量 */ +export const QUALITY_DOC_REF = '《质量方向分析》' + +export const QLT_TIME_AXIS = '投诉主时间轴=C3登记日期（registerDate）；统计单元=投诉条数（c3Code）' + +export const QLT_ADMISSION_DENOM = '入院量分母=入院表 cyQty 按医院+产品汇总（演示未按月份与投诉月严格对齐）' diff --git a/analytics-demo-web/src/layouts/AppLayout.vue b/analytics-demo-web/src/layouts/AppLayout.vue new file mode 100644 index 0000000..5e76285 --- /dev/null +++ b/analytics-demo-web/src/layouts/AppLayout.vue @@ -0,0 +1,131 @@ + + + + + diff --git a/analytics-demo-web/src/lib/aggregate.ts b/analytics-demo-web/src/lib/aggregate.ts new file mode 100644 index 0000000..e3dddf3 --- /dev/null +++ b/analytics-demo-web/src/lib/aggregate.ts @@ -0,0 +1,287 @@ +import type { AeRecord, AdmissionRecord, ComplaintRecord } from '../types/domain' +import type { AnalysisContext } from '../types/analysis' + +const monthKey = (dateString: string): string => dateString.slice(0, 7) + +function parseDay(dateString: string): number { + return Date.parse(`${dateString}T00:00:00`) +} + +export function isSaeRecord(record: AeRecord): boolean { + return !!( + record.saeDeath || + record.saeLifeThreatening || + record.saeDisability || + record.saeHospitalization + ) +} + +/** CMP-AE-101：按发生日期的月度 AE 报告条数 */ +export function buildAeMonthlyByOccurrence(context: AnalysisContext) { + const counter = new Map() + context.ae.forEach((record) => { + const key = monthKey(record.occurrenceDate) + counter.set(key, (counter.get(key) ?? 0) + 1) + }) + const months = [...counter.keys()].sort() + return { + months, + values: months.map((item) => counter.get(item) ?? 0), + } +} + +/** 产品事件 Top（全期，按发生日期归属可选扩展；此处为全量计数） */ +export function buildPsurTopProducts(context: AnalysisContext) { + const counter = new Map() + context.ae.forEach((record) => { + counter.set(record.productName, (counter.get(record.productName) ?? 0) + 1) + }) + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, 6) + return { + labels: sorted.map((item) => item[0]), + values: sorted.map((item) => item[1]), + } +} + +function admissionMonthKey(row: AdmissionRecord): string { + return `${row.year}-${String(row.month).padStart(2, '0')}` +} + +/** 入院量：按年月汇总 cyQty（演示：不按产品拆，全量暴露） */ +function buildAdmissionQtyByMonth(context: AnalysisContext): Map { + const map = new Map() + context.admissions.forEach((row) => { + const key = admissionMonthKey(row) + map.set(key, (map.get(key) ?? 0) + row.cyQty) + }) + return map +} + +/** CMP-AE-201 简化：全局月度 PPM（AE 按发生月 / 入院量按业务月） */ +export function buildGlobalMonthlyPpm(context: AnalysisContext) { + const aeByMonth = new Map() + context.ae.forEach((r) => { + const k = monthKey(r.occurrenceDate) + aeByMonth.set(k, (aeByMonth.get(k) ?? 0) + 1) + }) + const qtyByMonth = buildAdmissionQtyByMonth(context) + const months = [...new Set([...aeByMonth.keys(), ...qtyByMonth.keys()])].sort() + const ppm = months.map((m) => { + const num = aeByMonth.get(m) ?? 0 + const den = qtyByMonth.get(m) ?? 0 + if (den <= 0) return null + return Number(((num / den) * 1_000_000).toFixed(2)) + }) + return { months, ppm } +} + +/** CMP-AE-501：SAE 报告条数（按发生月） */ +export function buildSaeMonthlyByOccurrence(context: AnalysisContext) { + const counter = new Map() + context.ae.forEach((record) => { + if (!isSaeRecord(record)) return + const key = monthKey(record.occurrenceDate) + counter.set(key, (counter.get(key) ?? 0) + 1) + }) + const months = [...counter.keys()].sort() + return { + months, + values: months.map((item) => counter.get(item) ?? 0), + } +} + +/** CMP-AE-502：SAE 占全部 AE 比例（按发生月） */ +export function buildSaeShareMonthly(context: AnalysisContext) { + const total = new Map() + const sae = new Map() + context.ae.forEach((r) => { + const k = monthKey(r.occurrenceDate) + total.set(k, (total.get(k) ?? 0) + 1) + if (isSaeRecord(r)) sae.set(k, (sae.get(k) ?? 0) + 1) + }) + const months = [...total.keys()].sort() + const shares = months.map((m) => { + const t = total.get(m) ?? 1 + const s = sae.get(m) ?? 0 + return Number(((s / t) * 100).toFixed(1)) + }) + return { months, shares } +} + +/** CMP-AE-601：省级 AE 报告数（发生日期全期） */ +export function buildProvinceAeCounts(context: AnalysisContext) { + const counter = new Map() + context.ae.forEach((r) => { + counter.set(r.province, (counter.get(r.province) ?? 0) + 1) + }) + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** CMP-AE-701：Lag = T_end(审核日期) − 登记日期，返回原始天数列表 */ +export function buildReportingLagDays(context: AnalysisContext): number[] { + return context.ae.map((r) => { + const lagMs = parseDay(r.reviewDate) - parseDay(r.registrationDate) + return Math.round(lagMs / 86400000) + }) +} + +/** CMP-AE-702 演示：≤15 天为合规 */ +export function buildReportingTimelinessRate(context: AnalysisContext, thresholdDays = 15) { + const lags = buildReportingLagDays(context) + const ok = lags.filter((d) => d >= 0 && d <= thresholdDays).length + const denom = lags.filter((d) => d >= 0).length || 1 + return { rate: Number(((ok / denom) * 100).toFixed(1)), sample: denom } +} + +/** CMP-AE-301：器械故障 Top */ +export function buildTopDeviceFailures(context: AnalysisContext, topN = 10) { + const counter = new Map() + context.ae.forEach((r) => { + const k = r.deviceFailure || '（空）' + counter.set(k, (counter.get(k) ?? 0) + 1) + }) + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + const total = context.ae.length || 1 + return { + labels: sorted.map((i) => i[0]), + values: sorted.map((i) => i[1]), + pct: sorted.map((i) => Number(((i[1] / total) * 100).toFixed(1))), + } +} + +export interface HeatmapCell { + injury: string + device: string + value: number +} + +/** CMP-AE-401 / 402：伤害×故障矩阵；saeOnly 为 true 时等同 CMP-AE-402 */ +export function buildInjuryDeviceMatrix(context: AnalysisContext, saeOnly: boolean): { + injuries: string[] + devices: string[] + matrix: number[][] + cells: HeatmapCell[] +} { + const rows = saeOnly ? context.ae.filter((r) => isSaeRecord(r)) : context.ae + const injuries = [...new Set(rows.map((r) => r.injuryExpression || '（空）'))].sort() + const devices = [...new Set(rows.map((r) => r.deviceFailure || '（空）'))].sort() + const idxI = new Map(injuries.map((v, i) => [v, i])) + const idxD = new Map(devices.map((v, i) => [v, i])) + const matrix = injuries.map(() => devices.map(() => 0)) + const cells: HeatmapCell[] = [] + rows.forEach((r) => { + const i = idxI.get(r.injuryExpression || '（空）') ?? 0 + const j = idxD.get(r.deviceFailure || '（空）') ?? 0 + matrix[i][j] += 1 + }) + for (let i = 0; i < injuries.length; i++) { + for (let j = 0; j < devices.length; j++) { + if (matrix[i][j] > 0) { + cells.push({ injury: injuries[i], device: devices[j], value: matrix[i][j] }) + } + } + } + return { injuries, devices, matrix, cells } +} + +export function buildComplaintPareto(context: AnalysisContext) { + const comboCounter = new Map() + context.complaints.forEach((record) => { + const key = `${record.productName} / ${record.faultType}` + comboCounter.set(key, (comboCounter.get(key) ?? 0) + 1) + }) + const sorted = [...comboCounter.entries()].sort((a, b) => b[1] - a[1]).slice(0, 8) + const total = sorted.reduce((sum, item) => sum + item[1], 0) || 1 + let cumulative = 0 + return { + labels: sorted.map((item) => item[0]), + bars: sorted.map((item) => item[1]), + line: sorted.map((item) => { + cumulative += item[1] + return Number(((cumulative / total) * 100).toFixed(1)) + }), + } +} + +export function buildBatchConcentration(context: AnalysisContext) { + const batchCounter = new Map() + context.complaints.forEach((record) => { + batchCounter.set(record.batchNo, (batchCounter.get(record.batchNo) ?? 0) + 1) + }) + const sorted = [...batchCounter.entries()].sort((a, b) => b[1] - a[1]).slice(0, 6) + return { + labels: sorted.map((item) => item[0]), + values: sorted.map((item) => item[1]), + } +} + +const MATCH_WINDOW_DAYS = 30 + +function daysBetween(a: string, b: string): number { + return Math.round((parseDay(a) - parseDay(b)) / 86400000) +} + +/** 主题 J：投诉 isAe 与 AE 匹配（发生日期 ↔ C3 登记） */ +export function buildComplianceMatching(context: AnalysisContext) { + const flagged = context.complaints.filter((c) => c.isAe) + let matched = 0 + let missed = 0 + const missedRows: ComplaintRecord[] = [] + + for (const c of flagged) { + const candidates = context.ae.filter( + (a) => + a.unitName === c.hospitalName && + a.productName === c.productName && + a.model === c.model && + Math.abs(daysBetween(a.occurrenceDate, c.registerDate)) <= MATCH_WINDOW_DAYS, + ) + if (candidates.length) { + matched += 1 + } else { + missed += 1 + missedRows.push(c) + } + } + + const total = flagged.length || 1 + const leakRate = Number(((missed / total) * 100).toFixed(1)) + + let lagCompliantFromRegistration = 0 + let lagSample = 0 + let lagCompliantFromC3 = 0 + for (const c of flagged) { + const candidates = context.ae.filter( + (a) => + a.unitName === c.hospitalName && + a.productName === c.productName && + a.model === c.model && + Math.abs(daysBetween(a.occurrenceDate, c.registerDate)) <= MATCH_WINDOW_DAYS, + ) + if (!candidates.length) continue + const best = candidates.reduce((prev, cur) => { + const da = Math.abs(daysBetween(cur.occurrenceDate, c.registerDate)) + const db = Math.abs(daysBetween(prev.occurrenceDate, c.registerDate)) + return da < db ? cur : prev + }) + lagSample += 1 + const lagReg = daysBetween(best.reviewDate, best.registrationDate) + if (lagReg >= 0 && lagReg <= 15) lagCompliantFromRegistration += 1 + const lagC3 = daysBetween(best.reviewDate, c.registerDate) + if (lagC3 >= 0 && lagC3 <= 15) lagCompliantFromC3 += 1 + } + + return { + flaggedTotal: flagged.length, + matched, + missed, + leakRate, + matchRate: Number(((matched / total) * 100).toFixed(1)), + timelinessFromRegistrationPct: + lagSample > 0 ? Number(((lagCompliantFromRegistration / lagSample) * 100).toFixed(1)) : 0, + timelinessFromC3Pct: lagSample > 0 ? Number(((lagCompliantFromC3 / lagSample) * 100).toFixed(1)) : 0, + lagSample, + missedRows, + } +} diff --git a/analytics-demo-web/src/lib/comprehensive-insights.ts b/analytics-demo-web/src/lib/comprehensive-insights.ts new file mode 100644 index 0000000..52ebad5 --- /dev/null +++ b/analytics-demo-web/src/lib/comprehensive-insights.ts @@ -0,0 +1,409 @@ +import type { AnalysisContext } from '../types/analysis' +import { getAnalysisDefinition } from '../config/analysis-config' +import { + buildAeMonthlyByOccurrence, + buildComplaintPareto, + buildComplianceMatching, + buildGlobalMonthlyPpm, + buildInjuryDeviceMatrix, + buildProvinceAeCounts, + buildPsurTopProducts, + buildReportingLagDays, + buildSaeMonthlyByOccurrence, + buildSaeShareMonthly, + buildTopDeviceFailures, + isSaeRecord, +} from './aggregate' +import { + buildBatchComplaintVsAeCounts, + buildComplaintBatchTop, + buildComplaintCloseCycleDays, + buildComplaintMonthly, + buildCompensationDist, + buildDefectConfirmedProductFault, + buildFaultByRegisterMonthMatrix, + buildHospitalAeVsAdmissionScatter, + buildHospitalComplaintVsAdmissionQty, + buildHospitalProductComplaintRate, + buildInvestigationConclusionDist, + buildIsAeRateByProduct, + buildProductComplaintHalfYearGrowth, + buildProvinceComplaintHalfYearGrowth, + buildTopFaultTypes, + buildTopHospitalsComplaints, + buildTopProductsComplaints, +} from './quality-aggregate' +import { + buildDealerComplaintRatePer1000, + buildDealerOpWrongRatePer1000, + buildOpWrongDealerCounts, + buildOpWrongHospitalTop, + buildProductOpWrongSharePct, + buildProvinceComplaintCounts, + buildProvinceComplaintRatePer1000, +} from './marketing-aggregate' + +export type InsightDimension = '合规' | '质量' | '营销' | '事件实质' + +export interface InsightRow { + dimension: InsightDimension + pageTitle: string + chartId: string + chartTitle: string + bullets: string[] +} + +const PAGE_ORDER: { key: string; dimension: InsightDimension }[] = [ + { key: 'compliance-psur', dimension: '合规' }, + { key: 'compliance-audit', dimension: '合规' }, + { key: 'quality-concentration', dimension: '质量' }, + { key: 'quality-trends', dimension: '质量' }, + { key: 'quality-complaint-sales', dimension: '质量' }, + { key: 'quality-complaint-investigation', dimension: '质量' }, + { key: 'quality-complaint-batch', dimension: '质量' }, + { key: 'quality-ae-cause', dimension: '质量' }, + { key: 'quality-ae-only', dimension: '质量' }, + { key: 'quality-ae-with-complaint', dimension: '质量' }, + { key: 'marketing-operation-training', dimension: '营销' }, + { key: 'marketing-region-dealer', dimension: '营销' }, + { key: 'substance-matrix', dimension: '事件实质' }, + { key: 'substance-seasonality', dimension: '事件实质' }, +] + +function seriesPeak(labels: T[], values: number[], unit: string): string[] { + if (!labels.length) return ['当前序列无有效数据点。'] + let maxI = 0 + let minI = 0 + for (let i = 1; i < values.length; i++) { + if (values[i] > values[maxI]) maxI = i + if (values[i] < values[minI]) minI = i + } + const sum = values.reduce((a, b) => a + b, 0) + const avg = sum / values.length + const bullets = [ + `统计范围内合计 ${sum}${unit}，覆盖 ${labels.length} 个序列点。`, + `峰值出现在「${labels[maxI]}」（${values[maxI]}${unit}）；低谷为「${labels[minI]}」（${values[minI]}${unit}）。`, + ] + if (values[maxI] > avg * 1.25) bullets.push('峰值明显高于均值，建议结合下钻维度核查是否存在集中爆发或外部因素。') + else bullets.push('波动相对温和，可继续跟踪后续周期是否突破历史区间。') + return bullets +} + +type Builder = (ctx: AnalysisContext) => string[] + +const INSIGHTS: Record = { + 'psur-monthly': (ctx) => { + const t = buildAeMonthlyByOccurrence(ctx) + return seriesPeak(t.months, t.values, ' 条 AE') + }, + 'psur-ppm': (ctx) => { + const p = buildGlobalMonthlyPpm(ctx) + const pairs = p.months.map((m, i) => ({ m, v: p.ppm[i] })) + const valid = pairs.filter((x) => x.v != null) as { m: string; v: number }[] + if (!valid.length) return ['多数月份缺少入院量分母，PPM 不可算；需检查入院数据覆盖。'] + const vals = valid.map((x) => x.v) + const maxI = vals.indexOf(Math.max(...vals)) + return [ + `可计算 PPM 的月份共 ${valid.length} 个；最高 PPM 出现在 ${valid[maxI].m}（${valid[maxI].v}）。`, + 'PPM 同时受分子（AE 条数）与分母（CY Qty）波动影响，解读时需双因子对照。', + ] + }, + 'psur-device-top': (ctx) => { + const top = buildTopDeviceFailures(ctx, 10) + if (!top.labels.length) return ['暂无器械故障字段数据。'] + return [ + `报告条数最多的器械故障表现为「${top.labels[0]}」（${top.values[0]} 条）。`, + `Top3 合计约占当期可分类故障的显著份额，适合作为 PSUR「常见原因」叙述抓手。`, + ] + }, + 'psur-product-top': (ctx) => { + const t = buildPsurTopProducts(ctx) + if (!t.labels.length) return ['暂无产品维度 AE。'] + return [`AE 条数最高的产品为「${t.labels[0]}」（${t.values[0]} 条）。`, '建议与投诉侧同产品趋势对照阅读，区分监管通道与市场通道信号。'] + }, + 'psur-sae-monthly': (ctx) => { + const s = buildSaeMonthlyByOccurrence(ctx) + return seriesPeak(s.months, s.values, ' 条 SAE') + }, + 'psur-sae-share': (ctx) => { + const s = buildSaeShareMonthly(ctx) + const avg = s.shares.reduce((a, b) => a + b, 0) / s.shares.length + const maxI = s.shares.indexOf(Math.max(...s.shares)) + return [ + `SAE 占全部 AE 比例月均约 ${avg.toFixed(1)}%。`, + `占比峰值出现在 ${s.months[maxI]}（${s.shares[maxI]}%），需关注是否伴随总量上升（量率齐升）。`, + ] + }, + 'psur-province': (ctx) => { + const p = buildProvinceAeCounts(ctx) + if (!p.labels.length) return ['暂无省级 AE 分布。'] + return [ + `AE 报告条数最多的省份为「${p.labels[0]}」（${p.values[0]} 条）。`, + '省级绝对量需结合人口与装机/入院暴露进一步做率化，再判「热区」。', + ] + }, + 'psur-lag-histogram': (ctx) => { + const lags = buildReportingLagDays(ctx).filter((d) => d >= 0) + if (!lags.length) return ['缺少可计算的滞后天数（审核日或登记日为空）。'] + const mean = lags.reduce((a, b) => a + b, 0) / lags.length + const ok = lags.filter((d) => d <= 15).length + return [ + `有效样本 ${lags.length} 条，上报滞后（审核−登记）均值约 ${mean.toFixed(1)} 天。`, + `其中 ≤15 天约占 ${((ok / lags.length) * 100).toFixed(1)}%（演示阈值）。`, + ] + }, + 'audit-summary-bar': (ctx) => { + const m = buildComplianceMatching(ctx) + return [ + `应报样本（投诉标记不良事件）共 ${m.flaggedTotal} 条，疑似漏报率 ${m.leakRate}%，匹配率 ${m.matchRate}%。`, + `匹配子集上，按登记与按 C3 起算的 ≤15 天占比分别为 ${m.timelinessFromRegistrationPct}% 与 ${m.timelinessFromC3Pct}%。`, + ] + }, + 'audit-counts-pie': (ctx) => { + const m = buildComplianceMatching(ctx) + return [`已匹配 ${m.matched} 条，疑似漏报 ${m.missed} 条。`, '饼图结构用于审计抽样框说明；漏报清单需进入逐条调查闭环。'] + }, + 'quality-pareto-chart': (ctx) => { + const p = buildComplaintPareto(ctx) + if (!p.labels.length) return ['暂无产品×故障组合数据。'] + return [ + `贡献最大的组合为「${p.labels[0]}」（${p.bars[0]} 条投诉）。`, + `Top 组合累计占比曲线末点约 ${p.line[p.line.length - 1]}%，可据此划定「80% 投诉池」优先改进范围。`, + ] + }, + 'quality-batch-chart': (ctx) => { + const b = buildComplaintBatchTop(ctx, 8) + if (!b.labels.length) return ['暂无批号信息。'] + return [`投诉集中度最高的批号为「${b.labels[0]}」（${b.values[0]} 条）。`, '建议对 Top 批号启动批次质量回溯并与 AE 批号对照。'] + }, + 'quality-hospital-top': (ctx) => { + const t = buildTopHospitalsComplaints(ctx, 8) + return [`投诉条数最多的医院为「${t.labels[0]}」（${t.values[0]} 条）。`, '医院端集中可与培训、跟台及备件策略联动。'] + }, + 'quality-product-fault-top': (ctx) => { + const t = buildTopFaultTypes(ctx, 8) + return [`频次最高的故障类型为「${t.labels[0]}」（${t.values[0]} 次）。`, '一维故障分布可与 Pareto 组合图交叉验证。'] + }, + 'trend-monthly': (ctx) => { + const t = buildComplaintMonthly(ctx) + return seriesPeak(t.months, t.values, ' 条投诉') + }, + 'trend-product-half': (ctx) => { + const g = buildProductComplaintHalfYearGrowth(ctx) + return [ + `按上下半年对比，满足「增速≥20%」预警规则的产品共 ${g.length} 个（演示规则）。`, + g.length ? `预警列表首项产品为「${g[0].product}」，建议结合 Pareto 与批号视图复核。` : '当前样本未触发产品增速预警，可结合更长窗口观察。', + ] + }, + 'trend-product-alert': (ctx) => { + const g = buildProductComplaintHalfYearGrowth(ctx) + return [ + g.length + ? `预警列表首位产品为「${g[0].product}」，建议优先安排工程/质量联合复盘。` + : '未识别到达阈的增速异常产品（或样本不足）。', + ] + }, + 'trend-province-half': (ctx) => { + const rows = buildProvinceComplaintHalfYearGrowth(ctx) + const hit = rows.filter((r) => r.hit) + return [ + `共统计 ${rows.length} 个省份上下半年投诉量。`, + hit.length ? `其中 ${hit.length} 个省下半年相对上半年增幅≥20%，需关注区域侧原因。` : '未识别省级增速达阈信号。', + ] + }, + 'qc-sales-scatter': (ctx) => { + const pts = buildHospitalComplaintVsAdmissionQty(ctx) + const hi = [...pts].sort((a, b) => b.complaints - a.complaints)[0] + return [ + `共 ${pts.length} 家医院同时具有投诉与入院量数据。`, + hi ? `投诉条数最多的是「${hi.hospital}」（${hi.complaints} 条，cyQty 汇总 ${hi.cyQty}）。` : '', + '散点偏离带可提示「相对入院量投诉偏多」的医院，需结合床位与产品结构复核。', + ].filter(Boolean) + }, + 'qc-sales-rate': (ctx) => { + const rows = buildHospitalProductComplaintRate(ctx) + const top = rows[0] + if (!top) return ['暂无医院×产品投诉率数据。'] + return [ + `医院×产品维度投诉率（件/千件）最高为「${top.hospital} / ${top.product}」（${top.ratePer1000}）。`, + '率化结果对入院量分母敏感，脚注需固定为 CY Qty 与对齐键版本。', + ] + }, + 'qc-inv-pie': (ctx) => { + const d = buildInvestigationConclusionDist(ctx) + const top = d[0] + return top ? [`调查结论占比最高为「${top[0]}」（${top[1]} 条）。`, '结构变化适合按季度监控，识别「产品缺陷成立」是否抬升。'] : ['暂无调查结论数据。'] + }, + 'qc-defect-bar': (ctx) => { + const d = buildDefectConfirmedProductFault(ctx) + return d.labels.length + ? [`「产品缺陷成立」场景下，最高频组合为「${d.labels[0]}」（${d.values[0]} 条）。`, '该池子应进入 CAPA/设计变更输入优先级队列。'] + : ['暂无产品缺陷成立记录。'] + }, + 'qc-comp-pie': (ctx) => { + const d = buildCompensationDist(ctx) + const top = d[0] + return top ? [`赔付方式占比最高为「${top[0]}」（${top[1]} 次）。`, '可与缺陷成立子集交叉，观察质量失败外显成本结构。'] : ['暂无赔付数据。'] + }, + 'qc-product-top': (ctx) => { + const t = buildTopProductsComplaints(ctx, 8) + return [`投诉条数最多的产品为「${t.labels[0]}」（${t.values[0]} 条）。`, '与调查/赔付饼图联读可快速定位「问题产品」。'] + }, + 'qc-batch-ae': (ctx) => { + const rows = buildBatchComplaintVsAeCounts(ctx).filter((r) => r.complaints + r.aeReports > 0) + if (!rows.length) return ['暂无可对照的批号双通道数据。'] + const top = [...rows].sort((a, b) => b.complaints + b.aeReports - (a.complaints + a.aeReports))[0] + return [ + `批号「${top.batchNo}」投诉 ${top.complaints} 条、AE ${top.aeReports} 条，合计通道压力最大（演示口径）。`, + '双通道同升批号应优先纳入监管沟通与质量联合调查。', + ] + }, + 'qc-close-cycle': (ctx) => { + const days = buildComplaintCloseCycleDays(ctx) + if (!days.length) return ['缺少关闭日期或登记日期，无法计算周期。'] + const mean = days.reduce((a, b) => a + b, 0) / days.length + return [`投诉关闭周期（关闭−登记）均值约 ${mean.toFixed(1)} 天。`, '分布右尾偏长通常与补件、调查反复或跨部门协同有关。'] + }, + 'ae-scatter-hosp': (ctx) => { + const pts = buildHospitalAeVsAdmissionScatter(ctx) + const hi = [...pts].sort((a, b) => b.aeCount - a.aeCount)[0] + return [ + `共 ${pts.length} 家医院具备 AE 与入院量对照数据。`, + hi ? `AE 条数最多的是「${hi.hospital}」（${hi.aeCount} 条）。` : '', + '该图为报告行为异常筛查视角，不等同于医院医疗质量差。', + ].filter(Boolean) + }, + 'ae-upgrade-rate': (ctx) => { + const rows = buildIsAeRateByProduct(ctx) + const top = [...rows].sort((a, b) => b.ratePct - a.ratePct)[0] + return top + ? [`升级率（是否不良事件=是）最高的产品为「${top.product}」（${top.ratePct}%）。`, '跨 BU 对比可反映上报文化与流程差异。'] + : ['暂无升级率数据。'] + }, + 'ae-only-failure': (ctx) => { + const top = buildTopDeviceFailures(ctx, 8) + return [`未并发投诉的 AE 中，器械故障 Top1 为「${top.labels[0]}」。`, '用于理解「仅监管通道」事件形态。'] + }, + 'ae-only-monthly': (ctx) => { + const t = buildAeMonthlyByOccurrence(ctx) + return [`AE 仅报告维度下，月度峰值仍在「${t.months[t.values.indexOf(Math.max(...t.values))]}」。`, '与投诉月度曲线对照时注意双时间轴。'] + }, + 'ae-with-fault': (ctx) => { + const sub = ctx.complaints.filter((c) => c.isAe) + const m = new Map() + sub.forEach((c) => m.set(c.faultType, (m.get(c.faultType) ?? 0) + 1)) + const sorted = [...m.entries()].sort((a, b) => b[1] - a[1]) + return sorted.length + ? [`已升级投诉中最高频故障为「${sorted[0][0]}」。`, '可与 AE 伤害×故障矩阵叙事衔接。'] + : ['暂无已升级投诉。'] + }, + 'ae-with-monthly': (ctx) => { + const sub = ctx.complaints.filter((c) => c.isAe) + return [`当前样本中已升级投诉共 ${sub.length} 条。`, '登记月趋势用于观察升级投诉是否与活动期/政策窗口重叠。'] + }, + 'mkt-op-hospital': (ctx) => { + const d = buildOpWrongHospitalTop(ctx, 14) + return d.labels.length + ? [`操作不当投诉最多的医院为「${d.labels[0]}」（${d.values[0]} 条）。`, '适合作为院内操作培训与跟台加强的优先名单。'] + : ['无操作不当子集样本。'] + }, + 'mkt-op-dealer-count': (ctx) => { + const d = buildOpWrongDealerCounts(ctx, 14) + return d.labels.length + ? [`操作不当投诉条数最多的经销商为「${d.labels[0]}」（${d.values[0]} 条）。`, '渠道侧可安排联合巡院与标准操作复核。'] + : ['无操作不当子集样本。'] + }, + 'mkt-op-dealer-rate': (ctx) => { + const d = buildDealerOpWrongRatePer1000(ctx, 14) + return d.labels.length + ? [`操作不当率（件/千件）最高的经销商为「${d.labels[0]}」（${d.values[0]}）。`, '率化结果提示相对销量下的使用风险，不等于经销商储运问题。'] + : ['无法计算经销商操作不当率（分母或分子不足）。'] + }, + 'mkt-op-product-share': (ctx) => { + const d = buildProductOpWrongSharePct(ctx, 12) + return d.labels.length + ? [`操作不当占该产品全部投诉比例最高为「${d.labels[0]}」（${d.values[0]}%）。`, '说明书与数字化指导素材可优先迭代该产品。'] + : ['无操作不当占比数据。'] + }, + 'mkt-rg-province-rate': (ctx) => { + const d = buildProvinceComplaintRatePer1000(ctx, 16) + return d.labels.length + ? [`省级投诉率（件/千件）最高为「${d.labels[0]}」（${d.values[0]}）。`, '需与绝对量图对照，避免大省误判。'] + : ['暂无省级投诉率数据。'] + }, + 'mkt-rg-dealer-rate': (ctx) => { + const d = buildDealerComplaintRatePer1000(ctx, 16) + return d.labels.length + ? [`经销商维度投诉率（件/千件）最高为「${d.labels[0]}」（${d.values[0]}）。`, '可作为渠道辅导与考核的量化参考之一。'] + : ['暂无经销商投诉率数据。'] + }, + 'mkt-rg-province-count': (ctx) => { + const d = buildProvinceComplaintCounts(ctx, 14) + return d.labels.length + ? [`省级投诉绝对量最高为「${d.labels[0]}」（${d.values[0]} 条）。`, '与省级率图并列阅读，区分总量大与相对率高。'] + : ['暂无省级投诉分布。'] + }, + 'matrix-all': (ctx) => { + const { cells } = buildInjuryDeviceMatrix(ctx, false) + if (!cells.length) return ['暂无伤害×故障交叉数据。'] + const top = [...cells].sort((a, b) => b.value - a.value)[0] + return [ + `全量 AE 下最高频组合为「${top.injury} × ${top.device}」（${top.value} 条）。`, + '热力图用于 CAPA 优先级与医学叙述，不等同因果结论。', + ] + }, + 'matrix-sae': (ctx) => { + const rows = ctx.ae.filter((r) => isSaeRecord(r)) + const { cells } = buildInjuryDeviceMatrix(ctx, true) + if (!cells.length) return ['SAE 子集下暂无有效组合。'] + const top = [...cells].sort((a, b) => b.value - a.value)[0] + return [ + `当前 SAE 子集共 ${rows.length} 条；最高频伤害-故障组合为「${top.injury} × ${top.device}」。`, + '建议与严重医学评审及对外沟通材料要点对齐。', + ] + }, + 'seasonality-heatmap': (ctx) => { + const { cells } = buildFaultByRegisterMonthMatrix(ctx) + if (!cells.length) return ['暂无故障×月份数据。'] + const top = [...cells].sort((a, b) => b.value - a.value)[0] + return [ + `投诉侧「故障×登记月」强度最高单元为「${top.fault} / ${top.month}」（${top.value} 条）。`, + '探索性结论需结合气候/医院排班等外部变量再验证。', + ] + }, + 'seasonality-monthly-total': (ctx) => { + const t = buildComplaintMonthly(ctx) + const maxI = t.values.indexOf(Math.max(...t.values)) + return [`投诉总量峰值月份为 ${t.months[maxI]}（${t.values[maxI]} 条）。`, '与热力图行合计应对齐，用于读整体季节性背景。'] + }, +} + +export function buildComprehensiveInsightRows(context: AnalysisContext): InsightRow[] { + const rows: InsightRow[] = [] + for (const { key, dimension } of PAGE_ORDER) { + const def = getAnalysisDefinition(key) + if (!def) continue + for (const sec of def.sections) { + for (const chart of sec.charts) { + if (chart.placeholder) continue + if (!chart.optionBuilder) continue + const builder = INSIGHTS[chart.id] + const bullets = builder ? builder(context) : ['该图表已接入数据视图；结论规则尚未注册，可在 comprehensive-insights.ts 中补充。'] + rows.push({ + dimension, + pageTitle: def.title, + chartId: chart.id, + chartTitle: chart.title, + bullets, + }) + } + } + } + return rows +} + +export function groupInsightsByDimension(rows: InsightRow[]): Record { + const init: Record = { 合规: [], 质量: [], 营销: [], 事件实质: [] } + for (const r of rows) init[r.dimension].push(r) + return init +} diff --git a/analytics-demo-web/src/lib/marketing-aggregate.ts b/analytics-demo-web/src/lib/marketing-aggregate.ts new file mode 100644 index 0000000..96841fd --- /dev/null +++ b/analytics-demo-web/src/lib/marketing-aggregate.ts @@ -0,0 +1,158 @@ +import type { AnalysisContext } from '../types/analysis' +import { buildHospitalProvinceMap } from './quality-aggregate' + +const OP_MISCONDUCT = '操作不当' + +/** 医院 → 经销商（入院量表众数） */ +export function buildHospitalDealerMap(context: AnalysisContext): Map { + const count = new Map>() + for (const a of context.admissions) { + if (!count.has(a.hospitalName)) count.set(a.hospitalName, new Map()) + const inner = count.get(a.hospitalName)! + const d = a.dealerName || '（空）' + inner.set(d, (inner.get(d) ?? 0) + 1) + } + const m = new Map() + for (const [h, dmap] of count) { + const top = [...dmap.entries()].sort((x, y) => y[1] - x[1])[0] + if (top) m.set(h, top[0]) + } + return m +} + +export function filterOperationMisconductComplaints(context: AnalysisContext) { + return context.complaints.filter((c) => c.conclusion === OP_MISCONDUCT) +} + +/** MKT-OP-101 */ +export function buildOpWrongHospitalTop(context: AnalysisContext, topN = 15) { + const counter = new Map() + for (const c of filterOperationMisconductComplaints(context)) { + counter.set(c.hospitalName, (counter.get(c.hospitalName) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** MKT-OP-102 */ +export function buildOpWrongDealerCounts(context: AnalysisContext, topN = 15) { + const dealerMap = buildHospitalDealerMap(context) + const counter = new Map() + for (const c of filterOperationMisconductComplaints(context)) { + const d = dealerMap.get(c.hospitalName) ?? '（未映射经销商）' + counter.set(d, (counter.get(d) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** MKT-OP-103 */ +export function buildDealerOpWrongRatePer1000(context: AnalysisContext, topN = 15) { + const dealerMap = buildHospitalDealerMap(context) + const num = new Map() + for (const c of filterOperationMisconductComplaints(context)) { + const d = dealerMap.get(c.hospitalName) ?? '（未映射经销商）' + num.set(d, (num.get(d) ?? 0) + 1) + } + const den = new Map() + for (const a of context.admissions) { + const d = a.dealerName || '（空）' + den.set(d, (den.get(d) ?? 0) + a.cyQty) + } + const dealers = [...new Set([...num.keys(), ...den.keys()])] + const rows = dealers + .map((d) => { + const n = num.get(d) ?? 0 + const q = den.get(d) ?? 0 + return { dealer: d, n, q, rate: q > 0 ? (n / q) * 1000 : 0 } + }) + .filter((r) => r.n > 0 && r.q > 0) + .sort((a, b) => b.rate - a.rate) + .slice(0, topN) + return { labels: rows.map((r) => r.dealer), values: rows.map((r) => Number(r.rate.toFixed(3))) } +} + +/** MKT-OP-104 */ +export function buildProductOpWrongSharePct(context: AnalysisContext, topN = 15) { + const total = new Map() + const wrong = new Map() + for (const c of context.complaints) { + const p = c.productName + total.set(p, (total.get(p) ?? 0) + 1) + if (c.conclusion === OP_MISCONDUCT) wrong.set(p, (wrong.get(p) ?? 0) + 1) + } + const rows = [...total.keys()] + .map((p) => { + const t = total.get(p) ?? 1 + const w = wrong.get(p) ?? 0 + return { p, pct: t > 0 ? (w / t) * 100 : 0, w } + }) + .filter((r) => r.w > 0) + .sort((a, b) => b.pct - a.pct) + .slice(0, topN) + return { labels: rows.map((r) => r.p), values: rows.map((r) => Number(r.pct.toFixed(1))) } +} + +/** MKT-RG-201 */ +export function buildProvinceComplaintRatePer1000(context: AnalysisContext, topN = 20) { + const hp = buildHospitalProvinceMap(context) + const num = new Map() + for (const c of context.complaints) { + const p = hp.get(c.hospitalName) ?? '（未映射）' + num.set(p, (num.get(p) ?? 0) + 1) + } + const den = new Map() + for (const a of context.admissions) { + const p = a.province || '（空）' + den.set(p, (den.get(p) ?? 0) + a.cyQty) + } + const provinces = [...new Set([...num.keys(), ...den.keys()])] + const rows = provinces + .map((p) => { + const n = num.get(p) ?? 0 + const q = den.get(p) ?? 0 + return { province: p, n, q, rate: q > 0 ? (n / q) * 1000 : 0 } + }) + .filter((r) => r.q > 0) + .sort((a, b) => b.rate - a.rate) + .slice(0, topN) + return { labels: rows.map((r) => r.province), values: rows.map((r) => Number(r.rate.toFixed(3))) } +} + +/** MKT-RG-202 */ +export function buildDealerComplaintRatePer1000(context: AnalysisContext, topN = 20) { + const hd = buildHospitalDealerMap(context) + const num = new Map() + for (const c of context.complaints) { + const d = hd.get(c.hospitalName) ?? '（未映射经销商）' + num.set(d, (num.get(d) ?? 0) + 1) + } + const den = new Map() + for (const a of context.admissions) { + const d = a.dealerName || '（空）' + den.set(d, (den.get(d) ?? 0) + a.cyQty) + } + const dealers = [...new Set([...num.keys(), ...den.keys()])] + const rows = dealers + .map((d) => { + const n = num.get(d) ?? 0 + const q = den.get(d) ?? 0 + return { dealer: d, n, q, rate: q > 0 ? (n / q) * 1000 : 0 } + }) + .filter((r) => r.q > 0) + .sort((a, b) => b.rate - a.rate) + .slice(0, topN) + return { labels: rows.map((r) => r.dealer), values: rows.map((r) => Number(r.rate.toFixed(3))) } +} + +/** MKT-RG-203：省级投诉条数（绝对量） */ +export function buildProvinceComplaintCounts(context: AnalysisContext, topN = 15) { + const hp = buildHospitalProvinceMap(context) + const counter = new Map() + for (const c of context.complaints) { + const p = hp.get(c.hospitalName) ?? '（未映射）' + counter.set(p, (counter.get(p) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} diff --git a/analytics-demo-web/src/lib/mock-data.ts b/analytics-demo-web/src/lib/mock-data.ts new file mode 100644 index 0000000..a94937c --- /dev/null +++ b/analytics-demo-web/src/lib/mock-data.ts @@ -0,0 +1,32 @@ +import type { AeRecord, AdmissionRecord, ComplaintRecord } from '../types/domain' +import type { AnalysisContext } from '../types/analysis' + +let cachedContext: AnalysisContext | null = null + +/** 供页面刷新：下次重新 fetch mock JSON */ +export function invalidateAnalysisContextCache(): void { + cachedContext = null +} + +async function loadJson(url: string): Promise { + const response = await fetch(url) + if (!response.ok) { + throw new Error(`Failed to load ${url}`) + } + return response.json() as Promise +} + +export async function loadAnalysisContext(): Promise { + if (cachedContext) { + return cachedContext + } + + const [ae, complaints, admissions] = await Promise.all([ + loadJson('/mock/ae.json'), + loadJson('/mock/complaint.json'), + loadJson('/mock/admission.json'), + ]) + + cachedContext = { ae, complaints, admissions } + return cachedContext +} diff --git a/analytics-demo-web/src/lib/qa-resolve.ts b/analytics-demo-web/src/lib/qa-resolve.ts new file mode 100644 index 0000000..0113e19 --- /dev/null +++ b/analytics-demo-web/src/lib/qa-resolve.ts @@ -0,0 +1,170 @@ +import type { AnalysisContext } from '../types/analysis' +import { + buildAeMonthlyByOccurrence, + buildComplianceMatching, + buildProvinceAeCounts, + buildSaeShareMonthly, +} from './aggregate' +import { buildInvestigationConclusionDist } from './quality-aggregate' +import { buildOpWrongHospitalTop, buildProvinceComplaintRatePer1000 } from './marketing-aggregate' + +function norm(q: string): string { + return q.trim().toLowerCase().replace(/\s+/g, '') +} + +function monthCount(context: AnalysisContext, ym: string): number { + const { months, values } = buildAeMonthlyByOccurrence(context) + const i = months.indexOf(ym) + return i >= 0 ? values[i] : 0 +} + +export interface QaResult { + matched: boolean + /** preset | heuristic | none */ + source: string + answer: string +} + +/** 演示用：示例问题全文（下拉选项） */ +export const QA_SAMPLE_QUESTIONS: string[] = [ + '为什么11月的AE数量是10月的2倍还多？', + '2025年3月和8月的AE报告条数各是多少？为什么差异大？', + '哪个省份的AE报告条数最多？', + '上报合规审计里，疑似漏报率是多少？', + '操作不当投诉最多的医院是哪家？', + '省级投诉率（每千件入院量）最高的省份是哪个？', + '调查结论中占比最高的是哪一类？', + 'SAE占全部AE的比例大约多少？', + '当前演示数据里有多少条投诉记录？', +] + +/** + * Demo：根据问题关键词与当前 mock 聚合结果生成回答。 + * 正式上线可替换为调用大模型，并把 context 摘要与知识库片段作为 prompt。 + */ +export function resolveQaAnswer(question: string, context: AnalysisContext): QaResult { + const q = norm(question) + if (!q) { + return { matched: false, source: 'none', answer: '请输入问题后点击「获取答案」。' } + } + + // —— 与示例问题强相关 —— + if (q.includes('11月') && q.includes('10月') && (q.includes('ae') || q.includes('不良'))) { + const y2024_10 = monthCount(context, '2024-10') + const y2024_11 = monthCount(context, '2024-11') + const m3 = monthCount(context, '2025-03') + const m8 = monthCount(context, '2025-08') + const ratio = y2024_10 > 0 ? (y2024_11 / y2024_10).toFixed(2) : '—' + return { + matched: true, + source: 'preset', + answer: [ + '【数据口径】AE 条数按《合规方向分析》约定：统计单元为「报告条数」，时间轴为「发生日期」所在公历月。', + `【您问的年份对比】当前数据集中 **2024-10** 为 **${y2024_10}** 条，**2024-11** 为 **${y2024_11}** 条，倍数约为 **${ratio} 倍**，并未达到「2 倍还多」。`, + `【同数据集内反差更大的例子】**2025-03** 为 **${m3}** 条，**2025-08** 为 **${m8}** 条，相对落差更明显，通常与当月上报批次、产品结构与偶发聚集事件有关；正式分析建议按产品/省/注册证下钻并排除重复报告规则后再结论。`, + '【Demo 说明】上线后由 AI 结合上述聚合与业务知识库生成自然语言解释，并可自动附带下钻图表链接。', + ].join('\n'), + } + } + + if ((q.includes('2025') && q.includes('3月') && q.includes('8月')) || (q.includes('三月') && q.includes('八月'))) { + const a = monthCount(context, '2025-03') + const b = monthCount(context, '2025-08') + return { + matched: true, + source: 'preset', + answer: `按发生月聚合：**2025-03** 为 **${a}** 条 AE，**2025-08** 为 **${b}** 条。差异主要来自样本在月间的随机分布及产品结构；若需因果解释，应叠加产品、省份、是否 SAE 等切片（Demo 由规则直接读数）。`, + } + } + + if ((q.includes('省份') || q.includes('省')) && (q.includes('ae') || q.includes('不良'))) { + const p = buildProvinceAeCounts(context) + return { + matched: true, + source: 'data', + answer: `AE 按「发生日期」全量统计下，报告条数最多的省份为 **${p.labels[0]}**（**${p.values[0]}** 条）。第二名：${p.labels[1] ?? '—'}（${p.values[1] ?? '—'}）。`, + } + } + + if (q.includes('漏报') || (q.includes('合规') && q.includes('审计'))) { + const m = buildComplianceMatching(context) + return { + matched: true, + source: 'data', + answer: `在「投诉标记为不良事件」的基准集合（共 **${m.flaggedTotal}** 条）上，疑似漏报 **${m.missed}** 条，**漏报率 ${m.leakRate}%**（匹配规则：医院+产品+型号一致且 AE 发生日与 C3 登记日相差≤30 天，详见合规审计页）。`, + } + } + + if (q.includes('操作不当') && (q.includes('医院') || q.includes('哪家'))) { + const h = buildOpWrongHospitalTop(context, 5) + return { + matched: true, + source: 'data', + answer: `调查结论为「操作不当」的投诉中，条数最多的医院是 **${h.labels[0]}**（**${h.values[0]}** 条）。可与营销「操作不当与培训」页图表交叉验证。`, + } + } + + if (q.includes('投诉率') && (q.includes('省') || q.includes('省级'))) { + const r = buildProvinceComplaintRatePer1000(context, 5) + return { + matched: true, + source: 'data', + answer: `按《营销方向分析》MKT-RG-201 口径（投诉经医院映射到省，分母为同省入院 CY Qty 汇总，率=条数/Qty×1000），**${r.labels[0]}** 的投诉率最高，为 **${r.values[0]}**（件/千件）。`, + } + } + + if (q.includes('调查结论') || q.includes('结论占比')) { + const d = buildInvestigationConclusionDist(context) + const top = d[0] + return { + matched: true, + source: 'data', + answer: top + ? `当前投诉样本中，调查结论占比最高的是 **「${top[0]}」**（**${top[1]}** 条）。完整分布见质量方向「调查与赔付关系」页饼图。` + : '暂无调查结论数据。', + } + } + + if ((q.includes('sae') || q.includes('严重')) && (q.includes('比例') || q.includes('占比'))) { + const s = buildSaeShareMonthly(context) + const avg = (s.shares.reduce((a, b) => a + b, 0) / s.shares.length).toFixed(1) + return { + matched: true, + source: 'data', + answer: `SAE 占全部 AE 的月度比例（按发生月）在样本期内平均值约 **${avg}%**；具体曲线见合规 PSUR 页「SAE 占比」图。`, + } + } + + if (q.includes('投诉') && (q.includes('多少条') || q.includes('几条') || q.includes('几条记录') || q.includes('记录'))) { + const n = context.complaints.length + return { + matched: true, + source: 'data', + answer: `当前已加载的投诉（mock）共 **${n}** 条，与入院量、不良事件表一并用于本 Demo 各页图表与问答。`, + } + } + + // 模糊：仅「投诉最多医院」 + if (q.includes('投诉') && q.includes('医院') && q.includes('最多')) { + const hp = new Map() + for (const c of context.complaints) { + hp.set(c.hospitalName, (hp.get(c.hospitalName) ?? 0) + 1) + } + const top = [...hp.entries()].sort((a, b) => b[1] - a[1])[0] + return { + matched: true, + source: 'data', + answer: `全部投诉（不区分调查结论）条数最多的医院是 **${top[0]}**（**${top[1]}** 条）。`, + } + } + + return { + matched: false, + source: 'none', + answer: [ + '【Demo】未命中内置问题模板。请尝试上方「示例问题」一键填入，或提问中包含以下主题关键词：', + '「10月」「11月」「AE」；「省份」「AE」；「漏报」「合规」；「操作不当」「医院」；「投诉率」「省」；「调查结论」等。', + '【上线后】由 AI 读取数仓宽表、本项目的指标口径文档（合规/质量/营销/综合分析）及权限内历史结论，生成可追溯回答。', + ].join('\n'), + } +} diff --git a/analytics-demo-web/src/lib/quality-aggregate.ts b/analytics-demo-web/src/lib/quality-aggregate.ts new file mode 100644 index 0000000..f1bfafc --- /dev/null +++ b/analytics-demo-web/src/lib/quality-aggregate.ts @@ -0,0 +1,272 @@ +import type { AnalysisContext } from '../types/analysis' + +const monthKey = (dateString: string): string => dateString.slice(0, 7) + +/** 医院→省份：按入院量行频次取众数 */ +export function buildHospitalProvinceMap(context: AnalysisContext): Map { + const count = new Map>() + for (const a of context.admissions) { + if (!count.has(a.hospitalName)) count.set(a.hospitalName, new Map()) + const inner = count.get(a.hospitalName)! + inner.set(a.province, (inner.get(a.province) ?? 0) + 1) + } + const m = new Map() + for (const [h, pmap] of count) { + const top = [...pmap.entries()].sort((x, y) => y[1] - x[1])[0] + if (top) m.set(h, top[0]) + } + return m +} + +/** QLT-BTH-101：批号投诉条数 Top */ +export function buildComplaintBatchTop(context: AnalysisContext, topN = 8) { + const counter = new Map() + for (const c of context.complaints) { + const label = c.batchNo?.trim() ? c.batchNo : '（未填批号）' + counter.set(label, (counter.get(label) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** 投诉按登记月 */ +export function buildComplaintMonthly(context: AnalysisContext) { + const counter = new Map() + for (const c of context.complaints) { + const k = monthKey(c.registerDate) + counter.set(k, (counter.get(k) ?? 0) + 1) + } + const months = [...counter.keys()].sort() + return { months, values: months.map((m) => counter.get(m) ?? 0) } +} + +/** QLT-CNC-301：医院投诉条数 Top */ +export function buildTopHospitalsComplaints(context: AnalysisContext, topN = 8) { + const counter = new Map() + for (const c of context.complaints) { + counter.set(c.hospitalName, (counter.get(c.hospitalName) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** QLT-CNC-302：产品投诉条数 Top */ +export function buildTopProductsComplaints(context: AnalysisContext, topN = 8) { + const counter = new Map() + for (const c of context.complaints) { + counter.set(c.productName, (counter.get(c.productName) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** QLT-CNC-303：故障类型 Top */ +export function buildTopFaultTypes(context: AnalysisContext, topN = 10) { + const counter = new Map() + for (const c of context.complaints) { + const k = c.faultType || '（空）' + counter.set(k, (counter.get(k) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, topN) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** QLT-INV-501：调查结论分布 */ +export function buildInvestigationConclusionDist(context: AnalysisContext) { + const counter = new Map() + for (const c of context.complaints) { + const k = c.conclusion || '（空）' + counter.set(k, (counter.get(k) ?? 0) + 1) + } + return [...counter.entries()].sort((a, b) => b[1] - a[1]) +} + +/** QLT-CST-601：赔付结论分布 */ +export function buildCompensationDist(context: AnalysisContext) { + const counter = new Map() + for (const c of context.complaints) { + const k = c.compensation || '（空）' + counter.set(k, (counter.get(k) ?? 0) + 1) + } + return [...counter.entries()].sort((a, b) => b[1] - a[1]) +} + +/** QLT-INV-502：产品缺陷成立 → 产品×故障 */ +export function buildDefectConfirmedProductFault(context: AnalysisContext) { + const counter = new Map() + for (const c of context.complaints) { + if (c.conclusion !== '产品缺陷成立') continue + const key = `${c.productName} / ${c.faultType}` + counter.set(key, (counter.get(key) ?? 0) + 1) + } + const sorted = [...counter.entries()].sort((a, b) => b[1] - a[1]).slice(0, 10) + return { labels: sorted.map((i) => i[0]), values: sorted.map((i) => i[1]) } +} + +/** QLT-TRN-703 演示：按登记月份 H1(1–6月) vs H2(7–12月) 产品投诉增速 ≥20% */ +export function buildProductComplaintHalfYearGrowth(context: AnalysisContext) { + const h1 = new Map() + const h2 = new Map() + for (const c of context.complaints) { + const mo = Number.parseInt(c.registerDate.slice(5, 7), 10) + const p = c.productName + if (mo <= 6) h1.set(p, (h1.get(p) ?? 0) + 1) + else h2.set(p, (h2.get(p) ?? 0) + 1) + } + const products = [...new Set([...h1.keys(), ...h2.keys()])] + const rows: { product: string; firstHalf: number; secondHalf: number; growthPct: number | null }[] = [] + for (const p of products) { + const a = h1.get(p) ?? 0 + const b = h2.get(p) ?? 0 + let growthPct: number | null = null + if (a === 0 && b > 0) growthPct = null + else if (a > 0) growthPct = Number((((b - a) / a) * 100).toFixed(1)) + if (a > 0 && (b - a) / a >= 0.2) rows.push({ product: p, firstHalf: a, secondHalf: b, growthPct }) + if (a === 0 && b >= 2) rows.push({ product: p, firstHalf: a, secondHalf: b, growthPct: null }) + } + return rows.sort((x, y) => y.secondHalf - x.secondHalf) +} + +/** QLT-TRN-704 演示：省维度 H1 vs H2 */ +export function buildProvinceComplaintHalfYearGrowth(context: AnalysisContext) { + const hp = buildHospitalProvinceMap(context) + const h1 = new Map() + const h2 = new Map() + for (const c of context.complaints) { + const prov = hp.get(c.hospitalName) ?? '（未映射省）' + const mo = Number.parseInt(c.registerDate.slice(5, 7), 10) + if (mo <= 6) h1.set(prov, (h1.get(prov) ?? 0) + 1) + else h2.set(prov, (h2.get(prov) ?? 0) + 1) + } + const provinces = [...new Set([...h1.keys(), ...h2.keys()])] + const rows: { province: string; firstHalf: number; secondHalf: number; hit: boolean }[] = [] + for (const prov of provinces) { + const a = h1.get(prov) ?? 0 + const b = h2.get(prov) ?? 0 + const hit = a > 0 && (b - a) / a >= 0.2 + rows.push({ province: prov, firstHalf: a, secondHalf: b, hit }) + } + return rows.sort((x, y) => y.secondHalf - x.secondHalf) +} + +/** QLT-RPT-802：关闭周期（天）= 关闭日期 − C3登记日期 */ +export function buildComplaintCloseCycleDays(context: AnalysisContext): number[] { + return context.complaints + .map((c) => { + const ms = Date.parse(`${c.closeDate}T00:00:00`) - Date.parse(`${c.registerDate}T00:00:00`) + return Math.round(ms / 86400000) + }) + .filter((d) => Number.isFinite(d) && d >= 0) +} + +/** QLT-AE-1003：医院 AE 条数 vs 入院量 cyQty 汇总（AE 时间轴=发生日期） */ +export function buildHospitalAeVsAdmissionScatter(context: AnalysisContext) { + const hospitals = new Set() + context.ae.forEach((a) => hospitals.add(a.unitName)) + context.admissions.forEach((a) => hospitals.add(a.hospitalName)) + const points: { hospital: string; aeCount: number; cyQty: number }[] = [] + for (const h of hospitals) { + const aeCount = context.ae.filter((a) => a.unitName === h).length + const cyQty = context.admissions.filter((a) => a.hospitalName === h).reduce((s, a) => s + a.cyQty, 0) + if (cyQty > 0) points.push({ hospital: h, aeCount, cyQty }) + } + return points +} + +/** QLT-SAL-901：医院+产品 投诉率 = 投诉条数 / cyQty 汇总 */ +export function buildHospitalProductComplaintRate(context: AnalysisContext) { + const cMap = new Map() + for (const c of context.complaints) { + const k = `${c.hospitalName}\t${c.productName}` + cMap.set(k, (cMap.get(k) ?? 0) + 1) + } + const qMap = new Map() + for (const a of context.admissions) { + const k = `${a.hospitalName}\t${a.productName}` + qMap.set(k, (qMap.get(k) ?? 0) + a.cyQty) + } + const rows: { hospital: string; product: string; complaints: number; cyQty: number; ratePer1000: number }[] = [] + for (const [k, comp] of cMap) { + const [hospital, product] = k.split('\t') + const qty = qMap.get(k) ?? 0 + const ratePer1000 = qty > 0 ? Number(((comp / qty) * 1000).toFixed(3)) : 0 + rows.push({ hospital, product, complaints: comp, cyQty: qty, ratePer1000 }) + } + return rows.sort((a, b) => b.ratePer1000 - a.ratePer1000) +} + +/** QLT-AE-1001：按产品维度的升级率（是否不良事件=是） */ +export function buildIsAeRateByProduct(context: AnalysisContext) { + const tot = new Map() + const yes = new Map() + for (const c of context.complaints) { + tot.set(c.productName, (tot.get(c.productName) ?? 0) + 1) + if (c.isAe) yes.set(c.productName, (yes.get(c.productName) ?? 0) + 1) + } + const products = [...tot.keys()].sort() + return products.map((p) => ({ + product: p, + ratePct: Number((((yes.get(p) ?? 0) / (tot.get(p) ?? 1)) * 100).toFixed(1)), + })) +} + +/** 故障类型 × 登记月 计数（热力图源数据） */ +export function buildFaultByRegisterMonthMatrix(context: AnalysisContext) { + const faults = [...new Set(context.complaints.map((c) => c.faultType || '（空）'))].sort() + const months = [...new Set(context.complaints.map((c) => monthKey(c.registerDate)))].sort() + const idxF = new Map(faults.map((v, i) => [v, i])) + const idxM = new Map(months.map((v, i) => [v, i])) + const matrix = faults.map(() => months.map(() => 0)) + const cells: { fault: string; month: string; value: number }[] = [] + for (const c of context.complaints) { + const f = c.faultType || '（空）' + const m = monthKey(c.registerDate) + const i = idxF.get(f) ?? 0 + const j = idxM.get(m) ?? 0 + matrix[i][j] += 1 + } + for (let i = 0; i < faults.length; i++) { + for (let j = 0; j < months.length; j++) { + if (matrix[i][j] > 0) cells.push({ fault: faults[i], month: months[j], value: matrix[i][j] }) + } + } + return { faults, months, cells, matrix } +} + +/** 医院维度：投诉条数 vs 入院 cyQty 汇总（用于销售/入院关联散点） */ +export function buildHospitalComplaintVsAdmissionQty(context: AnalysisContext) { + const cMap = new Map() + for (const c of context.complaints) { + cMap.set(c.hospitalName, (cMap.get(c.hospitalName) ?? 0) + 1) + } + const qMap = new Map() + for (const a of context.admissions) { + qMap.set(a.hospitalName, (qMap.get(a.hospitalName) ?? 0) + a.cyQty) + } + const hospitals = [...new Set([...cMap.keys(), ...qMap.keys()])] + return hospitals.map((h) => ({ + hospital: h, + complaints: cMap.get(h) ?? 0, + cyQty: qMap.get(h) ?? 0, + })) +} + +/** QLT-BTH-104 简化：批号在投诉侧与 AE 侧的条数对照（同批号字符串） */ +export function buildBatchComplaintVsAeCounts(context: AnalysisContext) { + const cMap = new Map() + for (const c of context.complaints) { + if (!c.batchNo?.trim() || c.batchNo === 'NA') continue + cMap.set(c.batchNo, (cMap.get(c.batchNo) ?? 0) + 1) + } + const aMap = new Map() + for (const a of context.ae) { + if (!a.batchNo?.trim()) continue + aMap.set(a.batchNo, (aMap.get(a.batchNo) ?? 0) + 1) + } + const batches = [...new Set([...cMap.keys(), ...aMap.keys()])].sort() + return batches.map((b) => ({ + batchNo: b, + complaints: cMap.get(b) ?? 0, + aeReports: aMap.get(b) ?? 0, + })) +} diff --git a/analytics-demo-web/src/main.ts b/analytics-demo-web/src/main.ts new file mode 100644 index 0000000..c2eb5d9 --- /dev/null +++ b/analytics-demo-web/src/main.ts @@ -0,0 +1,16 @@ +import { createApp } from 'vue' +import { createPinia } from 'pinia' +import ElementPlus from 'element-plus' +import 'element-plus/dist/index.css' +import './assets/styles/index.scss' +import './assets/styles/common.scss' +import './style.css' +import App from './App.vue' +import router from './router' +import { useAuthStore } from './stores/useAuth' + +const app = createApp(App) +const pinia = createPinia() +app.use(pinia) +useAuthStore(pinia).hydrateFromStorage() +app.use(router).use(ElementPlus).mount('#app') diff --git a/analytics-demo-web/src/router/index.ts b/analytics-demo-web/src/router/index.ts new file mode 100644 index 0000000..571a5fa --- /dev/null +++ b/analytics-demo-web/src/router/index.ts @@ -0,0 +1,61 @@ +import { createRouter, createWebHistory } from 'vue-router' +import AppLayout from '../layouts/AppLayout.vue' +import AnalysisView from '../views/AnalysisView.vue' +import ComprehensiveInsightsView from '../views/ComprehensiveInsightsView.vue' +import LoginView from '../views/LoginView.vue' +import QaView from '../views/QaView.vue' +import { allLeaves } from '../config/menu' +import { useAuthStore } from '../stores/useAuth' + +const routes = [ + { + path: '/login', + name: 'login', + component: LoginView, + meta: { public: true, title: '登录' }, + }, + { + path: '/', + component: AppLayout, + meta: { requiresAuth: true }, + redirect: '/qa/chat', + children: allLeaves.map((leaf) => ({ + path: leaf.path.replace('/', ''), + component: + leaf.view === 'comprehensive' ? ComprehensiveInsightsView : leaf.view === 'qa' ? QaView : AnalysisView, + meta: { + title: leaf.title, + analysisKey: leaf.analysisKey, + strategyRef: leaf.strategyRef, + pillar: leaf.pillar, + requiresAuth: true, + }, + })), + }, +] + +const router = createRouter({ + history: createWebHistory(), + routes, +}) + +router.beforeEach((to) => { + const auth = useAuthStore() + if (!auth.token) auth.hydrateFromStorage() + + if (to.meta.public) { + if (auth.isAuthenticated && to.name === 'login') { + return { path: '/qa/chat', replace: true } + } + return true + } + + if (!auth.isAuthenticated) { + const redirect = to.path !== '/login' && to.fullPath ? to.fullPath : undefined + return redirect ? { path: '/login', query: { redirect } } : { path: '/login' } + } + + return true +}) + +export default router diff --git a/analytics-demo-web/src/stores/useAuth.ts b/analytics-demo-web/src/stores/useAuth.ts new file mode 100644 index 0000000..d78ef6f --- /dev/null +++ b/analytics-demo-web/src/stores/useAuth.ts @@ -0,0 +1,36 @@ +import { defineStore } from 'pinia' + +const STORAGE_KEY = 'bdae-demo-session' + +/** 演示账号：用户名与密码均为 Demo（区分大小写） */ +export const DEMO_USERNAME = 'Demo' +export const DEMO_PASSWORD = 'Demo' + +export const useAuthStore = defineStore('auth', { + state: () => ({ + /** 非空即视为已登录（演示用固定令牌） */ + token: '' as string, + }), + getters: { + isAuthenticated: (s) => Boolean(s.token), + }, + actions: { + /** 从 sessionStorage 恢复（刷新页面保持登录） */ + hydrateFromStorage() { + const v = sessionStorage.getItem(STORAGE_KEY) + if (v) this.token = v + }, + login(username: string, password: string): boolean { + if (username === DEMO_USERNAME && password === DEMO_PASSWORD) { + this.token = 'demo' + sessionStorage.setItem(STORAGE_KEY, 'demo') + return true + } + return false + }, + logout() { + this.token = '' + sessionStorage.removeItem(STORAGE_KEY) + }, + }, +}) diff --git a/analytics-demo-web/src/stores/useGlobalFilters.ts b/analytics-demo-web/src/stores/useGlobalFilters.ts new file mode 100644 index 0000000..517c369 --- /dev/null +++ b/analytics-demo-web/src/stores/useGlobalFilters.ts @@ -0,0 +1,16 @@ +import { defineStore } from 'pinia' + +export const useGlobalFilters = defineStore('global-filters', { + state: () => ({ + yearRange: [2024, 2026] as [number, number], + businessUnit: '全部', + keyword: '', + }), + actions: { + reset() { + this.yearRange = [2024, 2026] + this.businessUnit = '全部' + this.keyword = '' + }, + }, +}) diff --git a/analytics-demo-web/src/style.css b/analytics-demo-web/src/style.css new file mode 100644 index 0000000..af95b62 --- /dev/null +++ b/analytics-demo-web/src/style.css @@ -0,0 +1,10 @@ +* { + box-sizing: border-box; +} + +/* body / #app 基础样式见 assets/styles/index.scss */ + +#app { + width: 100%; + min-height: 100vh; +} diff --git a/analytics-demo-web/src/types/analysis.ts b/analytics-demo-web/src/types/analysis.ts new file mode 100644 index 0000000..f9752f6 --- /dev/null +++ b/analytics-demo-web/src/types/analysis.ts @@ -0,0 +1,43 @@ +import type { EChartsOption } from 'echarts' +import type { AeRecord, AdmissionRecord, ComplaintRecord } from './domain' + +export type PillarType = 'goal' | 'monitor' | 'diagnose' | 'act' + +export interface AnalysisContext { + ae: AeRecord[] + complaints: ComplaintRecord[] + admissions: AdmissionRecord[] +} + +/** 图表说明：取数范围 + 分析逻辑（质量方向等页面统一展示） */ +export interface ChartExplain { + dataScope: string + analysisLogic: string +} + +export interface ChartDefinition { + id: string + title: string + /** 一句话摘要，可放在卡片标题行右侧 */ + description?: string + /** 取数范围与分析逻辑（与《质量方向分析》等指标文档对齐） */ + chartExplain?: ChartExplain + placeholder?: boolean + optionBuilder?: (context: AnalysisContext) => EChartsOption +} + +export interface AnalysisSection { + id: string + title: string + strategyRefs: string[] + charts: ChartDefinition[] +} + +export interface AnalysisPageDefinition { + key: string + title: string + pillar: PillarType + strategyRef: string + subtitle: string + sections: AnalysisSection[] +} diff --git a/analytics-demo-web/src/types/domain.ts b/analytics-demo-web/src/types/domain.ts new file mode 100644 index 0000000..637d5f4 --- /dev/null +++ b/analytics-demo-web/src/types/domain.ts @@ -0,0 +1,54 @@ +/** 不良事件报告（统计单元：报告条数，见合规方向分析 §1.4） */ +export interface AeRecord { + reportCode: string + /** 发生日期 — AE 主时间轴 */ + occurrenceDate: string + /** 登记日期 — 获知日代理 */ + registrationDate: string + unitName: string + businessUnit: string + productName: string + registrationNo: string + model: string + batchNo: string + injuryExpression: string + deviceFailure: string + /** 审核日期 — 演示中作为 T_end（报告闭环终点） */ + reviewDate: string + province: string + /** SAE 严重标准（任一为 true 即计入 SAE 子集） */ + saeDeath?: boolean + saeLifeThreatening?: boolean + saeDisability?: boolean + saeHospitalization?: boolean +} + +export interface ComplaintRecord { + c3Code: string + model: string + batchNo: string + registrationNo: string + productName: string + hospitalName: string + faultType: string + registerDate: string + isAe: boolean + conclusion: string + compensation: string + closeDate: string +} + +export interface AdmissionRecord { + year: number + month: number + hospitalName: string + dealerName: string + province: string + bu: string + productName: string + cyQty: number + lyQty: number + growthQtyPct: number + cyAmt: number + growthAmtPct: number +} diff --git a/analytics-demo-web/src/views/AnalysisView.vue b/analytics-demo-web/src/views/AnalysisView.vue new file mode 100644 index 0000000..32cd736 --- /dev/null +++ b/analytics-demo-web/src/views/AnalysisView.vue @@ -0,0 +1,93 @@ + + + + + diff --git a/analytics-demo-web/src/views/ComprehensiveInsightsView.vue b/analytics-demo-web/src/views/ComprehensiveInsightsView.vue new file mode 100644 index 0000000..2f51f04 --- /dev/null +++ b/analytics-demo-web/src/views/ComprehensiveInsightsView.vue @@ -0,0 +1,130 @@ + + + + + diff --git a/analytics-demo-web/src/views/LoginView.vue b/analytics-demo-web/src/views/LoginView.vue new file mode 100644 index 0000000..83c7352 --- /dev/null +++ b/analytics-demo-web/src/views/LoginView.vue @@ -0,0 +1,121 @@ + + + + + diff --git a/analytics-demo-web/src/views/QaView.vue b/analytics-demo-web/src/views/QaView.vue new file mode 100644 index 0000000..045810a --- /dev/null +++ b/analytics-demo-web/src/views/QaView.vue @@ -0,0 +1,217 @@ + + + + + diff --git a/analytics-demo-web/tsconfig.app.json b/analytics-demo-web/tsconfig.app.json new file mode 100644 index 0000000..b6e9d59 --- /dev/null +++ b/analytics-demo-web/tsconfig.app.json @@ -0,0 +1,19 @@ +{ + "extends": "@vue/tsconfig/tsconfig.dom.json", + "compilerOptions": { + "ignoreDeprecations": "6.0", + "baseUrl": ".", + "paths": { + "@/*": ["./src/*"] + }, + "tsBuildInfoFile": "./node_modules/.tmp/tsconfig.app.tsbuildinfo", + "types": ["vite/client"], + + /* Linting */ + "noUnusedLocals": true, + "noUnusedParameters": true, + "erasableSyntaxOnly": true, + "noFallthroughCasesInSwitch": true + }, + "include": ["src/**/*.ts", "src/**/*.tsx", "src/**/*.vue"] +} diff --git a/analytics-demo-web/tsconfig.json b/analytics-demo-web/tsconfig.json new file mode 100644 index 0000000..1ffef60 --- /dev/null +++ b/analytics-demo-web/tsconfig.json @@ -0,0 +1,7 @@ +{ + "files": [], + "references": [ + { "path": "./tsconfig.app.json" }, + { "path": "./tsconfig.node.json" } + ] +} diff --git a/analytics-demo-web/tsconfig.node.json b/analytics-demo-web/tsconfig.node.json new file mode 100644 index 0000000..d3c52ea --- /dev/null +++ b/analytics-demo-web/tsconfig.node.json @@ -0,0 +1,24 @@ +{ + "compilerOptions": { + "tsBuildInfoFile": "./node_modules/.tmp/tsconfig.node.tsbuildinfo", + "target": "es2023", + "lib": ["ES2023"], + "module": "esnext", + "types": ["node"], + "skipLibCheck": true, + + /* Bundler mode */ + "moduleResolution": "bundler", + "allowImportingTsExtensions": true, + "verbatimModuleSyntax": true, + "moduleDetection": "force", + "noEmit": true, + + /* Linting */ + "noUnusedLocals": true, + "noUnusedParameters": true, + "erasableSyntaxOnly": true, + "noFallthroughCasesInSwitch": true + }, + "include": ["vite.config.ts"] +} diff --git a/analytics-demo-web/vite.config.ts b/analytics-demo-web/vite.config.ts new file mode 100644 index 0000000..1981649 --- /dev/null +++ b/analytics-demo-web/vite.config.ts @@ -0,0 +1,16 @@ +import path from 'node:path' +import { fileURLToPath } from 'node:url' +import { defineConfig } from 'vite' +import vue from '@vitejs/plugin-vue' + +const __dirname = path.dirname(fileURLToPath(import.meta.url)) + +// https://vite.dev/config/ +export default defineConfig({ + plugins: [vue()], + resolve: { + alias: { + '@': path.resolve(__dirname, 'src'), + }, + }, +}) diff --git a/scripts/convert_数据_to_mock_json.py b/scripts/convert_数据_to_mock_json.py new file mode 100644 index 0000000..363e6ac --- /dev/null +++ b/scripts/convert_数据_to_mock_json.py @@ -0,0 +1,200 @@ +""" +将「数据」目录下三份 Excel（与 #数据与表结构.md 一致）转换为 analytics-demo-web/public/mock/*.json。 +派生字段（源表无列时）： +- AE occurrenceDate / registrationDate：由审核日回溯生成，保证 occurrence < registration < review（演示用）。 +- AE province：由入院量表按医院名称众数映射。 +- AE SAE 四布尔：由「伤害表现」关键词启发式判定。 +- 入院 productName：将 MaterialDesc 映射到 AE∪投诉 产品名称集合（最长前缀包含匹配），便于与投诉率联表。 +""" + +from __future__ import annotations + +import hashlib +import json +from pathlib import Path + +import pandas as pd + +ROOT = Path(__file__).resolve().parents[1] +DATA_DIR = ROOT / "数据" +OUT_DIR = ROOT / "analytics-demo-web" / "public" / "mock" + + +def _d(v) -> pd.Timestamp | pd.NaTType: + if pd.isna(v): + return pd.NaT + return pd.to_datetime(v) + + +def _fmt(d: pd.Timestamp | pd.NaTType) -> str: + if pd.isna(d): + return "" + return d.strftime("%Y-%m-%d") + + +def _stable_int(s: str) -> int: + return int(hashlib.md5(s.encode("utf-8")).hexdigest()[:8], 16) + + +def infer_sae_flags(injury_text: str) -> dict[str, bool]: + t = injury_text or "" + return { + "saeDeath": ("死亡" in t) and ("非死亡" not in t), + "saeLifeThreatening": "危及生命" in t or "生命威胁" in t or "心跳骤停" in t, + "saeDisability": "残疾" in t or "功能障碍" in t, + "saeHospitalization": "住院" in t or "延长住院" in t or "住院时间延长" in t, + } + + +def map_material_to_product(material_desc: str, canonical_products: list[str]) -> str: + if not isinstance(material_desc, str) or not material_desc.strip(): + return "" + s = material_desc.strip() + for p in canonical_products: + if p and p in s: + return p + return s.split()[0] if " " in s else s + + +def main() -> None: + ae_path = DATA_DIR / "不良事件数据-模拟1000条-20260414.xlsx" + adm_path = DATA_DIR / "入院量数据-模拟1000条-20260414.xlsx" + cmp_path = DATA_DIR / "质量投诉数据-模拟1000条-20260414.xlsx" + + ae_df = pd.read_excel(ae_path, sheet_name=0) + adm_df = pd.read_excel(adm_path, sheet_name=0) + cmp_df = pd.read_excel(cmp_path, sheet_name=0) + cmp_df.columns = [str(c).replace("\n", "").strip() for c in cmp_df.columns] + + hosp_prov = ( + adm_df.groupby("HospitalName")["Province"] + .agg(lambda s: s.mode().iloc[0] if len(s.mode()) else (s.iloc[0] if len(s) else "")) + .to_dict() + ) + hospital_keys = sorted(hosp_prov.keys(), key=len, reverse=True) + # 入院量表仅覆盖部分医院；其余 AE 单位按常识补省（仅用于演示地图/省聚合） + province_override: dict[str, str] = { + "中国医科大学附属第一医院": "辽宁省", + "华中科技大学同济医学院附属协和医院": "湖北省", + "昆明医科大学第一附属医院": "云南省", + "天津市肿瘤医院": "天津市", + "重庆医科大学附属第一医院": "重庆市", + } + + def resolve_province(unit: str) -> str: + if unit in province_override: + return province_override[unit] + if unit in hosp_prov: + return str(hosp_prov[unit]).strip() + for h in hospital_keys: + if not h: + continue + if h in unit or unit in h: + return str(hosp_prov[h]).strip() + return "（未映射）" + + ae_products = set(ae_df["产品名称"].dropna().astype(str).unique()) + cmp_products = set(cmp_df["产品名称"].dropna().astype(str).unique()) + canonical_products = sorted(ae_products | cmp_products, key=len, reverse=True) + + ae_rows: list[dict] = [] + for _, row in ae_df.iterrows(): + code = str(row.get("报告编码", "")).strip() + review = _d(row.get("审核日期")) + if pd.isna(review): + continue + h = _stable_int(code) % 10000 + reg = review - pd.Timedelta(days=3 + (h % 6)) + occ = reg - pd.Timedelta(days=1 + (h % 12)) + unit = str(row.get("单位名称", "")).strip() + injury = str(row.get("伤害表现", "") or "").strip() + flags = infer_sae_flags(injury) + ae_rows.append( + { + "reportCode": code, + "occurrenceDate": _fmt(occ), + "registrationDate": _fmt(reg), + "unitName": unit, + "businessUnit": str(row.get("事业线", "") or "").strip(), + "productName": str(row.get("产品名称", "") or "").strip(), + "registrationNo": str(row.get("注册证编号/曾用注册证编号", "") or "").strip(), + "model": str(row.get("型号", "") or "").strip(), + "batchNo": str(row.get("产品批号", "") or "").strip(), + "injuryExpression": injury, + "deviceFailure": str(row.get("器械故障表现", "") or "").strip(), + "reviewDate": _fmt(review), + "province": resolve_province(unit) or "（未映射）", + **flags, + } + ) + + adm_rows: list[dict] = [] + for _, row in adm_df.iterrows(): + md = row.get("MaterialDesc") + pname = map_material_to_product(str(md) if md == md else "", canonical_products) + adm_rows.append( + { + "year": int(row["Year"]), + "month": int(row["Month"]), + "hospitalName": str(row.get("HospitalName", "") or "").strip(), + "dealerName": str(row.get("DealerName", "") or "").strip(), + "province": str(row.get("Province", "") or "").strip(), + "bu": str(row.get("BU", "") or "").strip(), + "productName": pname, + "cyQty": float(row.get("CY Qty", 0) or 0), + "lyQty": float(row.get("LY Qty", 0) or 0), + "growthQtyPct": round(float(row.get("Growth% Qty", 0) or 0) * 100, 4), + "cyAmt": float(row.get("CY Amt", 0) or 0), + "growthAmtPct": round(float(row.get("Growth% Amt", 0) or 0) * 100, 4), + } + ) + + def yn_to_bool(v) -> bool: + s = str(v).strip() + return s == "是" or s.lower() == "true" or s == "1" + + cmp_rows: list[dict] = [] + for _, row in cmp_df.iterrows(): + reg = _d(row.get("C3登记日期")) + if pd.isna(reg): + continue + close = _d(row.get("关闭日期")) + survey = _d(row.get("调查报告完成日期")) + if pd.isna(close): + close = survey if not pd.isna(survey) else reg + cmp_rows.append( + { + "c3Code": str(row.get("C3编号", "")).strip(), + "model": str(row.get("型号", "") or "").strip(), + "batchNo": str(row.get("批号", "") or "").strip(), + "registrationNo": str(row.get("注册证号", "") or "").strip(), + "productName": str(row.get("产品名称", "") or "").strip(), + "hospitalName": str(row.get("医院名称", "") or "").strip(), + "faultType": str(row.get("故障类型", "") or "").strip(), + "registerDate": _fmt(reg), + "isAe": yn_to_bool(row.get("是否不良事件")), + "conclusion": str(row.get("调查结论（处理结果）", "") or "").strip(), + "compensation": str(row.get("赔付结论", "") or "").strip(), + "closeDate": _fmt(close), + } + ) + + OUT_DIR.mkdir(parents=True, exist_ok=True) + (OUT_DIR / "ae.json").write_text( + json.dumps(ae_rows, ensure_ascii=False, indent=2), + encoding="utf-8", + ) + (OUT_DIR / "admission.json").write_text( + json.dumps(adm_rows, ensure_ascii=False, indent=2), + encoding="utf-8", + ) + (OUT_DIR / "complaint.json").write_text( + json.dumps(cmp_rows, ensure_ascii=False, indent=2), + encoding="utf-8", + ) + + print("Wrote", len(ae_rows), "ae,", len(adm_rows), "admission,", len(cmp_rows), "complaint ->", OUT_DIR) + + +if __name__ == "__main__": + main() diff --git a/vite.config.js b/vite.config.js new file mode 100644 index 0000000..8fead19 --- /dev/null +++ b/vite.config.js @@ -0,0 +1,143 @@ +import { defineConfig, loadEnv } from 'vite' +import vue from '@vitejs/plugin-vue' +import path, { resolve } from 'path' +import { VitePWA } from 'vite-plugin-pwa' +import { readFileSync } from 'fs' + +// https://vitejs.dev/config/ +export default defineConfig(({ command, mode }) => { + // 加载环境变量 + const env = loadEnv(mode, process.cwd(), '') + + return { + plugins: [ + vue(), + VitePWA({ + registerType: 'autoUpdate', + manifest: JSON.parse(readFileSync('./public/manifest.json', 'utf-8')), + workbox: { + // 增加文件大小限制以处理大文件 + maximumFileSizeToCacheInBytes: 10 * 1024 * 1024, // 10MB + // 自定义缓存策略 + runtimeCaching: [ + { + urlPattern: /^https:\/\/fonts\.googleapis\.com\/.*/i, + handler: 'CacheFirst', + options: { + cacheName: 'google-fonts-cache', + expiration: { + maxEntries: 10, + maxAgeSeconds: 60 * 60 * 24 * 365 // <== 365 days + } + } + }, + { + urlPattern: /^http:\/\/127\.0\.0\.1:8091\/.*/i, + handler: 'NetworkFirst', + options: { + cacheName: 'api-cache', + expiration: { + maxEntries: 50, + maxAgeSeconds: 60 * 60 * 24 // 24 hours + } + } + } + ] + }, + devOptions: { + enabled: true // 开发环境也启用 PWA + } + }) + ], + resolve: { + alias: { + '@': path.resolve(__dirname, 'src'), + }, + extensions: ['.mjs', '.js', '.ts', '.jsx', '.tsx', '.json', '.vue'] + }, + server: { + port: 3000, + host: '0.0.0.0', + open: true, + proxy: { + '/api': { + target: 'http://127.0.0.1:8091', + changeOrigin: true, + rewrite: (path) => path.replace(/^\/api/, '') + }, + // 添加日志以查看代理是否生效 + onProxyReq(proxyReq, req, res) { + console.log('代理请求:', req.method, req.url); + }, + onProxyRes(proxyRes, req, res) { + console.log('代理响应:', proxyRes.statusCode, req.url); + } + }, + fs: { + strict: true, + allow: ['..'] + } + }, + optimizeDeps: { + include: [ + 'vue', + 'vue-router', + 'pinia', + '@element-plus/icons-vue', + 'element-plus' + ] + }, + build: { + // 生产环境禁用 sourcemap 以节省内存 + sourcemap: mode === 'development', + chunkSizeWarningLimit: 3000, + // 启用压缩，减少输出文件大小 + minify: 'terser', + terserOptions: { + compress: { + // 移除 console 和 debugger + drop_console: mode === 'production', + drop_debugger: true + } + }, + rollupOptions: { + // 配置 Rollup 以处理大型项目 + maxParallelFileOps: 2, // 限制并行文件操作数量 + input: { + main: resolve(__dirname, 'index.html'), + // 为每个模块生成独立的HTML入口 + dashboard: resolve(__dirname, 'public/dashboard.html'), + crm: resolve(__dirname, 'public/crm.html'), + org: resolve(__dirname, 'public/org.html'), + task: resolve(__dirname, 'public/task.html'), + knowledge: resolve(__dirname, 'public/knowledge.html'), + email: resolve(__dirname, 'public/email.html'), + manager: resolve(__dirname, 'public/manager.html') + }, + output: { + // 确保文件名包含 hash，实现自动缓存失效 + entryFileNames: 'assets/[name]-[hash].js', + chunkFileNames: 'assets/[name]-[hash].js', + assetFileNames: 'assets/[name]-[hash].[ext]', + // 优化 chunk 分割策略 + manualChunks: { + // 框架相关 + 'vue-vendor': ['vue', 'vue-router', 'pinia'], + // UI 组件库 + 'element-plus': ['element-plus', '@element-plus/icons-vue'], + // 图表库 + 'echarts': ['echarts'], + // 表格组件 + 'vxe-table': ['vxe-table'], + // 编辑器相关 + 'editor': ['@umoteam/editor'], + // 其他工具库 + 'utils': ['crypto-js', 'axios'] + } + }, + // 外部化一些大型依赖（如果可能） + external: [] + } + } + } +}) diff --git a/分析策略/__pycache__/md_to_docx_convert.cpython-314.pyc b/分析策略/__pycache__/md_to_docx_convert.cpython-314.pyc new file mode 100644 index 0000000..76f3bc4 Binary files /dev/null and b/分析策略/__pycache__/md_to_docx_convert.cpython-314.pyc differ diff --git a/分析策略/md_to_docx_convert.py b/分析策略/md_to_docx_convert.py new file mode 100644 index 0000000..dec7eb0 --- /dev/null +++ b/分析策略/md_to_docx_convert.py @@ -0,0 +1,57 @@ +from pathlib import Path + +from docx import Document + + +def convert_md_to_docx(md_path: Path, docx_path: Path) -> None: + doc = Document() + + lines = md_path.read_text(encoding="utf-8").splitlines() + in_code = False + + for raw in lines: + line = raw.rstrip("\n") + + if line.strip().startswith("```"): + in_code = not in_code + continue + + if in_code: + p = doc.add_paragraph() + p.add_run(line) + continue + + if not line.strip(): + doc.add_paragraph("") + continue + + if line.startswith("# "): + doc.add_heading(line[2:].strip(), level=1) + continue + if line.startswith("## "): + doc.add_heading(line[3:].strip(), level=2) + continue + if line.startswith("### "): + doc.add_heading(line[4:].strip(), level=3) + continue + + if line.startswith("- "): + doc.add_paragraph(line[2:].strip(), style="List Bullet") + continue + + s = line.lstrip() + if len(s) > 2 and s[0].isdigit() and s[1] == "." and s[2] == " ": + doc.add_paragraph(s[3:].strip(), style="List Number") + continue + + # Markdown table rows are preserved as plain text lines for compatibility. + doc.add_paragraph(line) + + doc.save(str(docx_path)) + + +if __name__ == "__main__": + src = Path(r"d:\数据分析业务\ixa\药物警戒价值分析策略-正文.md") + dst = Path(r"d:\数据分析业务\ixa\药物警戒价值分析策略-正文.docx") + convert_md_to_docx(src, dst) + print(f"Written: {dst}") diff --git a/分析策略/合规方向分析.md b/分析策略/合规方向分析.md new file mode 100644 index 0000000..4001635 --- /dev/null +++ b/分析策略/合规方向分析.md @@ -0,0 +1,217 @@ +# 合规方向分析（落地说明） + +> 本文档由《贝朗医疗数据分析策略》**合规维度**拆分而来，面向药物警戒/器械警戒与合规团队，用于指标口径统一、开发实现与页面文案设计。 +> 质量、营销方向落地文件见 [质量方向分析.md](./质量方向分析.md)、[营销方向分析.md](./营销方向分析.md)；确认本文件结构与深度后，可按相同模板扩展。 + +--- + +## 0 分析指标文档化的最佳实践（摘要） + +在业界 KPI/指标管理实践中，单条指标建议至少具备以下要素，以保证「可复用、可对账、可演进」： + +| 要素 | 说明 | +|------|------| +| **业务定义** | 指标回答什么问题、与哪条法规/内控要求对齐（避免仅写图表名）。 | +| **可计算定义** | 分子/分母、集合判定规则、是否去重（事件级/病例级/报告级）。 | +| **维度与粒度** | 时间桶（日/周/月/季/年）、地理、产品、注册证、BU、严重度等。 | +| **过滤条件** | 纳入/排除规则（如草稿、重复报告、测试数据）。 | +| **数据来源与字段** | 主表、关联键、字段映射；多源时明确主从与优先级。 | +| **实现注意点** | 空值、时区、工作日与自然日、匹配窗口、分母缺失时的处理。 | +| **输出形态** | 图/表/卡片/地图/阈值告警；建议刷新频率与受众。 | +| **页面呈现用途** | 给产品经理/前端的一句话：该模块帮助用户完成什么决策或动作。 | + +书写**计算逻辑**时的建议： + +1. **先定义统计单元**：例如「一条不良事件报告」「一例患者伤害」「一次投诉闭环」——同一屏上不要混用。 +2. **公式显式化**：比例类写清分子分母；率类注明分母来源（销量、入院量、装机量等）及**口径版本**。 +3. **匹配类规则写清算法**：键字段、模糊匹配策略、时间窗（±N 天）、一对多时的择优规则。 +4. **与法规时限对齐**：将「15 天/45 天」等映射为可计算的日期差分规则，并单独配置节假日是否顺延（若业务需要）。 +5. **版本化**：口径变更时保留指标编码（如 `CMP-AE-001`），避免历史报表不可比。 + +以下各节按「分析主题 → 指标清单」组织；每条指标均含**计算逻辑/方法**与**页面呈现用途**。 + +--- + +## 1 策略定位与数据范围 + +### 1.1 业务目标 + +满足中国医疗器械不良事件监测相关法规与指南要求，支撑 **PSUR/定期风险评估**、**上报合规审计** 与 **趋势预警**；输出可被监管沟通引用的图、表与结构化指标。 + +### 1.2 适用对象 + +药物警戒（PV）/器械警戒、注册与合规、医学安全、必要时联动质量与风险管理。 + +### 1.3 主数据对象（与策略原文一致） + +| 对象 | 典型用途 | +|------|----------| +| 不良事件（AE）表 | 监管侧事件统计、严重度、伤害/故障分布、区域与趋势 | +| 投诉表 | 与 AE 交叉验证、上报时效起点、是否标记为不良事件 | +| 入院量/销售辅助数据 | **PPM 等发生率类指标的分母（暴露量）**，与 AE 产品在统一物料/产品维度对齐后汇总 | + +### 1.4 已定口径（全局默认，已确认） + +以下口径适用于本文件全部指标，除非在单条指标中另行标注「例外」。 + +| 项目 | 已定口径 | +|------|----------| +| **AE 主时间轴** | 以 **发生日期** 为准；年/季/月等时间桶均由该字段派生。 | +| **AE 统计单元** | **报告条数**（每条 AE 记录计 1，不做病例/患者去重，除非另建专项指标）。 | +| **PPM 分母** | **入院量**（与 AE 在同一产品对齐键上汇总同期入院量；汇总用 **Qty 或 Amt** 由数据模型择一固化并在报表脚注声明，全公司一致）。 | +| **获知日** | 采用 **登记日期**（作为法规/内控语境下「获知」在系统中的落库字段；用于上报时效类计算的起点，字段路径实现为 `不良事件.登记日期` 或主数据统一编码）。 | +| **SAE（严重不良事件）** | 按 **SAE 严重标准**判定，满足以下 **任一** 即归入 SAE 子集：**死亡**、**危及生命**、**导致残疾**、**导致住院或住院时间延长**（以 AE 表编码/多选字段 OR 逻辑汇总；底层码表由医学/PV 维护并与国家分类映射）。 | + +**说明**：主题 G「上报时效」在可配对样本上，计算 **`Lag = T_end − 登记日期`**，其中 `T_end` 为企业认定的**报告闭环终点日**（建议配置为 `审核日期` 或「首次提交监管/国家系统日期」，二选一全司统一）；法规 15 天/45 天等阈值对该 `Lag` 适用，事件是否适用「紧急/死亡」更短时限仍由企业规则表配置。 + +--- + +## 2 监管报告类分析（PSUR 与定期安全更新） + +### 2.1 主题 A：总体事件趋势 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-101** | 不良事件报告数（按时间桶） | **分子**：时间过滤落在各时间桶内、符合纳入规则的 AE **报告条数**。**时间过滤字段**：**发生日期**。**分母**：无。**维度**：年/季/月。**过滤**：排除测试/重复标记（若有字段）。 | **趋势总览卡片/折线图**：回答「事件量是否异常上升」，作为 PSUR「总体趋势」章节的封面指标。 | +| **CMP-AE-102** | 不良事件报告数（按注册证号 × 年） | 对 AE 按 `注册证编号` 与 **`发生日期` 所在公历年**（发生年）分组计数。 | **堆叠或分面折线**：识别「哪一个注册证贡献主要增量」，支撑注册证分级监管与再评价讨论。 | +| **CMP-AE-103** | 不良事件报告数（按主要产品/BU × 时间桶） | 通过产品主数据将 AE 产品映射到 **产品线/BU**，按 **发生日期** 落入的时间桶计数 **报告条数**。 | **管理驾驶舱分 BU 视图**：向事业部同步安全负荷，用于资源与对外沟通优先级。 | + +**实现注意**：监管报送若需「报告期」切片展示，可另建**辅助看板**按 `审核日期`/`录入日期` 复算，但与本文 **CMP-AE-*** 主口径不一致时须在页面显著标注，避免与按发生日的安全信号混读。 + +--- + +### 2.2 主题 B：发生率 / PPM 与过程控制图（SPC） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-201** | 产品级不良事件 PPM | **公式**：`PPM = (AE 报告数 / 同期入院量) × 1,000,000`。**分子**：按 **发生日期** 落入统计期的 AE **报告条数**。**分母**：同一统计期、与 AE 经 **产品对齐键** 匹配后的 **入院量** 汇总值（Qty 或 Amt 由模型固化，全司一致）。无分母或分母为 0 时：仅展示分子并灰显「率」或显示「N/A」。**维度**：产品/SKU/注册证。 | **PPM 趋势折线 + 脚注声明分母为入院量及字段**：支撑 PSUR「发生率」叙述。 | +| **CMP-AE-202** | BU/产品线分组 PPM | 在 CMP-AE-201 基础上，分子为 BU 内 AE **报告条数**之和，分母为 BU 内 **入院量**之和，再计算 PPM（禁止先算 SKU PPM 再简单平均）。 | **事业部对比条形图**：同一尺度下比较不同 BU 的安全负荷是否正常。 | +| **CMP-AE-203** | PPM 的 SPC 控制图（规则可选 Western Electric/Nelson） | 以连续时间序列为子组（如按月）：子组内 AE 数与入院量与 CMP-AE-201 一致；对 PPM 序列计算中心线、控制限及判异标注。分母波动大时优先 **U 图/P 图**（按子组入院量加权）。 | **预警型折线控件**：当点出界或连续同侧时高亮，服务「趋势预警」与管理层简报。 | + +--- + +### 2.3 主题 C：器械故障类型与伤害表现分布 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-301** | TOP10 器械故障表现占比 | 对 AE 的「器械故障表现」字段规范化编码后计数，取 Top10；**占比** = 该类型计数 / 当期有效 AE 总数 ×100%。 | **横向柱状图**：PSUR「常见原因/故障」小节，快速列出需工程评估的故障类型。 | +| **CMP-AE-302** | 伤害表现频次表 | 对「伤害表现」字段计数；可按 **是否属于 SAE 严重标准**（见 §1.4）分层小计。 | **表格 + 导出**：与监管分类对齐，用于医学评审与说明书/IFU 风险提示更新。 | + +--- + +### 2.4 主题 D：伤害表现 × 器械故障表现 交叉矩阵（热力图） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-401** | 伤害-故障组合计数矩阵 | 构建二维表：行=伤害表现，列=器械故障表现，单元格 = 满足 `(伤害,故障)` 组合的 **AE 报告条数**（默认以 **发生日期** 落入统计期过滤）。**可选标准化**：单元格显示占行百分比或占总量百分比。 | **热力图**：一眼识别「哪类故障最常伴随哪类伤害」，支撑 CAPA 与临床风险沟通。 | +| **CMP-AE-402** | SAE 子集下的伤害-故障矩阵 | 在 CMP-AE-401 上仅保留满足 **§1.4 SAE 严重标准**（死亡 / 危及生命 / 导致残疾 / 导致住院或住院时间延长 **之一**）的 AE **报告条数**。 | **风险聚焦视图**：对接严重结局组合模式，用于紧急医学评估与对外报告要点。 | +| **CMP-AE-403** | 按产品分层的典型组合 | 对每个主要产品复制 CMP-AE-401/402，或提供产品筛选器后重算。 | **产品安全档案内嵌模块**：说明「该产品典型故障-伤害模式」，与 PSUR 产品章节一致。 | + +*策略原文第 5.1 节与本主题同一分析主线；实现时建议共用同一语义指标，避免两套口径。* + +--- + +### 2.5 主题 E：严重不良事件（SAE）专项 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-501** | SAE 报告数（年/季） | 筛选满足 **§1.4 SAE 严重标准** 的 AE，按 **发生日期** 落入的年/季时间桶对 **报告条数** 计数。 | **SAE 趋势折线**：PSUR/风险管理会「严重事件」专段。 | +| **CMP-AE-502** | SAE 占全部 AE 比例 | `SAE 报告条数 / 当期全部 AE 报告条数 ×100%`；当期与桶边界均以 **发生日期** 为准。若 AE 表含非器械事件，先按业务规则限定器械范围再算。 | **占比卡片 + 趋势**：观察严重事件是否「量增」同时「占比增」。 | +| **CMP-AE-503** | SAE 分布（产品/医院/地区） | 在 SAE 子集（定义同 §1.4）上按维度聚合计数；可选 **SAE 率** = SAE 数 / 同期入院量（对齐键同 CMP-AE-201）。 | **地图/条形图**：定位高风险聚集点，支持现场调查与沟通名单。 | + +--- + +### 2.6 主题 F：分区域分布 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-601** | 省级 AE 报告数 | 按 **发生日期** 落入统计期的 AE，经省份（或医院→省份映射）聚合计 **报告条数**。 | **中国地图着色**：展示地理聚集，辅助供应链与批次假设。 | +| **CMP-AE-602** | 省级 AE 发生率（入院量分母） | `省 AE 报告条数 / 省入院量`；分子时间口径为 **发生日期**，分母为同期 **入院量** 按省汇总（字段 Qty/Amt 与产品对齐规则同 CMP-AE-201）。 | **地图 + 表格双视图**：区分「绝对量大」与「相对率高」，减少误判人口大省。 | +| **CMP-AE-603** | 区域 TOP 事件类型 | 对每个省，在该省当期 AE（**发生日期**）中取事件名称或故障类型的 TopN。 | **下钻表格**：从省到事件类型的快速穿透，用于区域医学联络准备材料。 | + +--- + +### 2.7 主题 G：投诉/不良事件上报时效性 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-701** | 单条 AE 上报滞后天数（获知→闭环） | **定义**：`Lag = T_end − 登记日期`。其中 **获知日** 已确认为 **`登记日期`**；`T_end` 为企业统一配置的**报告闭环终点日**（`审核日期` 或「首次提交监管/国家系统日期」二选一）。仅统计两日期均非空的 AE **报告条数**；若 `登记日期 > T_end` 则标为数据质量异常单。 | **直方图/箱线图**：展示从获知登记到闭环的滞后分布。 | +| **CMP-AE-702** | 法规时限合规率（15 天/45 天等） | 在 CMP-AE-701 可判定集合上，按事件分类（是否适用死亡/危及生命等**更短时限**，以企业规则表配置）分别比较 `Lag ≤ T`。**合规率** = 合规条数 / 可判定条数。 | **仪表盘阈值灯**：内控与审计应答「是否满足报告时限」。 | +| **CMP-AE-703** | 超窗案例清单 | 列出 `Lag > T` 的 AE **报告**及超窗天数、责任单元（若可解析）。 | **整改任务列表**：支持 CAPA 与流程 IT 改进闭环。 | + +*注：「15/45 天」是否顺延节假日可作为**可配置策略**，须在报表脚注固定输出；**与投诉 C3 登记的跨表时效**见 **CMP-CV-104**。* + +**投诉–AE 配对场景的补充口径（可选）**：若需保留「投诉登记 → AE 闭环」视角，可单列 `Lag₂ = T_end − 投诉.C3登记日期`（仅匹配成功子集），与 CMP-AE-701 **并存展示**，避免与获知日=登记日期口径混淆。 + +--- + +### 2.8 主题 H：注册证号安全档案（产品安全一览） + +对每一 `注册证编号`，输出一组**并列指标**（适合「一行一证」表 + 详情下钻）： + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-801** | 注册证维度 AE 累计报告数 | 按注册证汇总 AE **报告条数**；时间窗默认按 **发生日期**（如近 12 个月或上市至今可选）。 | **安全档案主列**：快速对比各证事件量。 | +| **CMP-AE-802** | 注册证维度关联投诉数 | 投诉表按 `注册证号` 与所选时间窗计数（若投诉侧主时间轴与 AE **发生日期** 不一致，须在档案页脚注分别说明两条时间轴）。 | **档案并列列**：同一证下市场端反馈量，辅助「市场-监管」一体叙事。 | +| **CMP-AE-803** | 注册证维度 PPM | 同 CMP-AE-201，在注册证粒度聚合。 | **排序列**：识别相对暴露下事件偏高的证。 | +| **CMP-AE-804** | 注册证维度 SAE 占比 | 该证 SAE 数 / 该证 AE 总数。 | **风险标签**：触发再评价/说明书更新讨论的候选证。 | +| **CMP-AE-805** | 注册证维度主要故障/伤害文本（Top3） | 对子集取故障表现、伤害表现各 Top3 及占比。 | **档案摘要区**：供注册与医学在会议中口述「典型模式」。 | + +**关联字段（与策略原文一致）**：不良事件.`注册证编号` ↔ 投诉.`注册证号`（需处理格式统一与历史别名映射）。 + +--- + +### 2.9 主题 I：补充分析（可选数据源） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-AE-901** | 新产品上市后 AE/PPM 与对照 | 定义「新产品」列表（获批/首销日期），上市后按周或月统计：AE 数以 **发生日期** 落入窗口的 **报告条数** 为准；PPM 分母为同期 **入院量**（同 CMP-AE-201）。与同类老产品或全局基准对照（可选置信区间）。 | **上市安全监测专页**：支持 PMCF/上市后研究计划的证据展示。 | +| **CMP-AE-902** | CAPA 实施前后 AE 趋势对比 | 以 `实施完成日` 为断点，对比前后等长窗口的 AE **报告条数**或 PPM（AE 时间轴 **发生日期**；注意外部混杂，页面提示「关联非因果」）。 | **改进叙事图**：对内对外说明「已采取控制措施」的佐证材料。 | + +--- + +## 3 合规行为分析：不良事件上报合规性审计 + +### 3.1 主题 J：投诉标记不良事件的「应报尽报」核对 + +**业务规则（与策略原文对齐）**：以投诉表中 `是否不良事件 = 是` 的记录为基准，检查在不良事件表中是否存在**可认定为同一事件**的对应记录。 + +**匹配逻辑建议（可配置）**： + +1. **强键**：`医院名称` ≈ `单位名称`（建议标准化：去空格、统一简称库）+ `产品名称` 一致 + `型号` 一致（若有）。 +2. **时间窗**：`投诉.C3登记日期` 与 **`不良事件.发生日期`** 之差在 **±W 天**内（W 默认如 30，可配置），与全篇 AE **主时间轴**一致。 +3. **一对多处理**：若多条 AE 命中，取 **`发生日期` 与投诉 C3 登记日期最接近** 的一条为「主匹配」；其余记为「重复报告」供人工复核。 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **CMP-CV-101** | 疑似漏报条数 | 基准集合中，**无任何**满足匹配规则的 AE 记录的投诉条数。 | **审计高亮列表**：逐条进入调查与补报流程。 | +| **CMP-CV-102** | 漏报率 | `疑似漏报条数 / 基准集合总条数 ×100%`。 | **合规 KPI 卡片**：季度汇报内控与管理层。 | +| **CMP-CV-103** | 匹配成功条数 | 基准集合中存在 ≥1 条 AE 匹配的投诉数。 | **过程能力参考**：与漏报率互补，用于评估匹配规则是否过严。 | +| **CMP-CV-104** | 上报时效合规率（投诉-AE 配对子集） | 在匹配成功子集上：**优先**对 AE 使用 **CMP-AE-701/702**（`Lag = T_end − 登记日期`）计算合规率；若业务需展示「投诉通道起点」则并列计算 `Lag₂ = T_end − 投诉.C3登记日期` 的合规率并在 UI 标注双口径。 | **联接视图**：同时看「有没有报」与「报得是否及时」，并区分获知登记 vs 投诉登记起点。 | + +**页面呈现用途（主题级）**：本分析模块整体用于回应《医疗器械不良事件监测和再评价管理办法》等法规中的**上报义务**内控证据，并可作为外审时的抽样框架说明。 + +--- + +## 4 与主策略文档的对应关系 + +| 主策略章节 | 本文档章节 | +|------------|------------| +| §2.1 用于监管报告（PSUR 各图表明细） | §2.1–§2.9 | +| §2.2 不良事件上报合规性审计 | §3.1 | +| §5.1 伤害表现 × 器械故障（与 §2.1.1 d 同一主线） | §2.4 | + +--- + +## 5 仍建议在数据模型层固化的细节（非口径争议） + +以下不影响 §1.4 已定业务口径，但需在 ETL/主数据 **一次拍板**，以保证全表可对账： + +1. **入院量汇总字段**：`Qty` 与 `Amt` 二选一作为 PPM 分母时的正式字段名及是否与财务口径一致。 +2. **AE–入院量产品对齐键**：物料号、本地产品码或注册证映射层级，及无法匹配时的归属规则（入「未匹配」桶或排除）。 +3. **SAE 判定实现**：AE 表上四个严重结局在字段层是四布尔、单选多级码表还是国家系统导出码；与 §1.4 四类的 SQL/规则表达式版本化存档。 +4. **`T_end` 字段**：审核完成日与「首次上传国家系统日」择一后的系统字段名及跨系统对时规则。 + +--- + +*文档版本：已纳入 §1.4 口径确认（发生日、报告条数、入院量分母、获知日=登记日期、SAE 四标准）；数仓命名与刷新 SLA 可另页维护。* diff --git a/分析策略/综合分析.md b/分析策略/综合分析.md new file mode 100644 index 0000000..a1cd047 --- /dev/null +++ b/分析策略/综合分析.md @@ -0,0 +1,66 @@ +# 综合分析（落地说明） + +> 本文档由《贝朗医疗数据分析策略》**画像与综合（§6–§7）**及跨维度复盘需求拆分，面向管理层、PMO、PV/质量/市场联席例会，用于**把合规、质量、营销各页图表的结论集中呈现**，形成一页式「数据读法」清单。 +> 维度落地文：[合规方向分析.md](./合规方向分析.md)、[质量方向分析.md](./质量方向分析.md)、[营销方向分析.md](./营销方向分析.md)。 + +--- + +## 1 目标与边界 + +### 1.1 业务目标 + +- **汇总读数**：对已实现图表的输出做**同一数据源上的二次解读**，避免各业务线只带走各自截图、口径不一致。 +- **支撑 §6–§7 演进**：当前版本以 **§7 综合联动**中的「多维度同屏复盘」为落点；**§6 客户画像**（高投诉高复购、赔付与增长）待数据字段齐备后接入同一汇总框架。 + +### 1.2 边界（当前 Demo） + +- 结论文案由前端 **`comprehensive-insights`** 规则基于 **`public/mock`** 聚合结果**自动生成**，属于**辅助阅读**而非审计结论；正式环境应可由规则引擎 + 人工批注替换。 +- **占位图**（无 `optionBuilder`）不参与汇总列表。 +- 每条结论建议控制在 **2～4 个要点**，与单图 `chartExplain`（取数范围/分析逻辑）互补：**后者讲口径，前者讲读法**。 + +--- + +## 2 汇总列表的信息结构 + +综合页每条对应「一张已实现图」，列表字段建议固定为： + +| 字段 | 说明 | +|------|------| +| **维度** | 合规 / 质量 / 营销 / 事件实质 | +| **所属分析页** | 与左侧菜单标题一致 | +| **图表名称** | 与页面卡片标题一致 | +| **图表 ID** | 与 `analysis-config` 中 `id` 一致，便于缺陷跟踪与版本对比 | +| **结论要点** | 无序列表，基于该图当前聚合结果的**规则化摘要**（见 §3） | + +--- + +## 3 结论生成规则（原则） + +1. **一数一结论**：优先输出「总量/极值/占比/斜率」中业务最敏感的一类，避免复述图表标题。 +2. **极值必报**：时间序列报峰值月份与数值；Top 图报 Top1 及与均值的倍数关系（若可算）。 +3. **率类脚注**：凡含入院量分母，结论中点明「千件」或「占比」与 **CY Qty** 口径，与《质量/营销方向分析》一致。 +4. **合规与质量分读**：AE 用发生日期、投诉用 C3 登记日期的图，结论中**不得合并**为同一句话的时间轴。 +5. **弱数据提示**：样本量过小或分母为 0 时，结论单条提示「不宜过度解读」。 + +各 `chartId` 与具体规则表达式见源码 `analytics-demo-web/src/lib/comprehensive-insights.ts`（随图表迭代同步维护）。 + +--- + +## 4 与主策略章节的对应关系 + +| 主策略 | 本文档 / 前端 | +|--------|----------------| +| §6 安全维度客户画像 | 预留；待复购/赔付与入院联动字段稳定后接入汇总列表 | +| §7 综合联动分析 | **综合分析**页：多维度图表结论列表；后续可扩展双轴矩阵结论块 | + +--- + +## 5 维护说明 + +- 新增图表时：在 `analysis-config.ts` 增加 `id` 后，于 **`comprehensive-insights.ts`** 注册同名 `chartId` 的结论生成函数（或显式标记「人工结论」占位）。 +- 更换 **Excel→mock** 数据后，结论随聚合结果变化，**无需改文案模板**（阈值类除外）。 +- 若需输出 Word/PPT，可由本列表导出 Markdown/CSV 再排版。 + +--- + +*文档版本：与前端「画像与综合 → 综合分析」菜单一致。* diff --git a/分析策略/营销方向分析.md b/分析策略/营销方向分析.md new file mode 100644 index 0000000..b487699 --- /dev/null +++ b/分析策略/营销方向分析.md @@ -0,0 +1,88 @@ +# 营销方向分析（落地说明） + +> 本文档由《贝朗医疗数据分析策略》**营销维度（§4）**拆分而来，面向市场、渠道、培训与客户成功团队，用于指标口径统一、开发实现与页面文案设计。 +> 合规与质量维度分别见 [合规方向分析.md](./合规方向分析.md)、[质量方向分析.md](./质量方向分析.md)。 + +指标文档化要素（业务定义、可计算定义、维度、过滤、数据来源、实现注意点、输出形态、页面用途）建议与 [合规方向分析.md](./合规方向分析.md) **§0** 保持一致；下文各节按「分析主题 → 指标清单」展开，指标编码前缀 **`MKT-`**。 + +--- + +## 1 策略定位与数据范围 + +### 1.1 业务目标 + +从**投诉**数据中识别可能与**使用培训、推广沟通、渠道服务**相关的信号（如「操作不当」集中、区域/经销商维度投诉率异常），支撑**培训计划、经销商辅导、产品说明书与数字化推广素材**的迭代；与质量方向的根因池（产品缺陷）**并列阅读**，避免将营销类信号误归为质量问题。 + +### 1.2 适用对象 + +市场部、渠道/经销商管理、应用培训、医学教育、KA/区域销售、客户成功。 + +### 1.3 主数据对象 + +| 对象 | 典型用途 | +|------|----------| +| **质量投诉表** | 调查结论、医院、产品、故障类型、C3登记日期；筛选「操作不当」子集 | +| **入院量表** | 将医院映射到 **Province、DealerName**；提供投诉率分母 **CY Qty**（或企业固化为 Amt） | + +字段级清单与关联见 `#数据与表结构.md`。 + +### 1.4 已定口径（全局默认） + +| 项目 | 建议口径 | +|------|----------| +| **投诉主时间轴** | **`C3登记日期`**（`registerDate`）；全篇营销投诉类指标默认一致。 | +| **投诉统计单元** | **投诉条数**（`c3Code` 唯一）。 | +| **「操作不当」子集** | 调查结论字段精确等于 **`操作不当`**（与主策略 §4.1 一致；若存在中英文混排需在 ETL 归一）。 | +| **医院 → 省 / 经销商** | 由入院量表按 **`HospitalName`** 聚合：对 **Province**、**DealerName** 取**众数**（出现频次最高）；一对多时在元数据层版本化存档。 | +| **率类分母** | **入院量 CY Qty** 在相同地理或经销商维度上汇总；演示与质量方向一致可用「件/千件」：**投诉条数 / CY Qty × 1000**；分母为 0 时该桶不计算率或标 N/A。 | +| **占比类** | 「操作不当占该产品全部投诉比例」= 该产品操作不当条数 / 该产品投诉总条数 ×100%。 | + +--- + +## 2 主题 A：操作不当与培训（主策略 §4.1） + +> 回答：哪些医院、哪些经销商覆盖区域、哪些产品更需要**培训与使用支持**，而非单纯质量缺陷。 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **MKT-OP-101** | 操作不当投诉医院 TopN | 子集：`调查结论 = 操作不当`；按 **`医院名称`** 计数投诉条数，降序取 TopN。 | **条形图**：培训现场名单与院内教育优先级。 | +| **MKT-OP-102** | 操作不当投诉经销商分布（条数） | 同上子集；每条投诉经 **`医院名称` → 入院量众数 DealerName`** 归入经销商后计数。 | **条形图**：渠道侧辅导与考核对象排序。 | +| **MKT-OP-103** | 经销商操作不当率（入院量分母） | 子集同上；**分子**=该经销商名下医院映射后的操作不当条数；**分母**=入院量表 **`DealerName`** 等于该经销商的 **CY Qty 汇总**；**率** = 分子/分母×1000（件/千件，与质量 QLT-SAL-901 量级一致便于对照）。 | **排序条形图**：识别「相对销量操作不当偏多」的经销商。 | +| **MKT-OP-104** | 产品操作不当占比 | 按 **`产品名称`**：`操作不当条数 / 该产品全部投诉条数 ×100%`；可设最小投诉量阈值再展示避免小样本。 | **条形图**：说明书/视频/数字化指导优先级。 | +| **MKT-OP-105**（可选） | 操作不当 × 故障类型 | 在操作不当子集上按 **`故障类型`** 计数 Top。 | **表格/条形**：判断是「通用操作」还是某类故障话术不清。 | + +--- + +## 3 主题 B：区域与经销商投诉率（主策略 §4.2） + +> 回答：哪些**省**、哪些**经销商**在「相对入院量」下投诉偏多，用于渠道储运、覆盖密度与客户支持资源的再分配（不等同于质量结论）。 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **MKT-RG-201** | 省级投诉率（入院量分母） | **分子**：投诉经医院→**省**映射后的条数（可全量投诉或限定时间窗）。**分母**：入院量表同一 **Province** 的 **CY Qty** 汇总。**率** = 分子/分母×1000。 | **省级排名条形图/地图**：区域资源与活动排期。 | +| **MKT-RG-202** | 经销商投诉率（入院量分母） | **分子**：投诉经医院→**DealerName（众数）** 归类计数。**分母**：入院量表 **DealerName** 维度 **CY Qty** 汇总。**率** = 分子/分母×1000。 | **经销商排名**：辅导、仓储、配送假设的优先验证名单。 | +| **MKT-RG-203**（可选） | 省级投诉条数（不分母） | 仅计数，用于与 MKT-RG-201 对照区分「绝对量大」与「相对率高」。 | **并列卡片或表**：避免人口大省误判。 | + +**实现注意**：同一医院在多经销商、多 BU 行中共存时，**众数规则**可能随月份切片变化，须在数据字典中固定；与质量方向 **医院×产品** 对齐键若不一致，应在页面脚注声明。 + +--- + +## 4 与主策略文档的对应关系 + +| 主策略章节 | 本文档章节 | +|------------|------------| +| §4.1 操作不当与投诉 | §2 | +| §4.2 区域与经销商投诉率 | §3 | + +--- + +## 5 仍建议在数据模型层固化的细节 + +1. **医院 → 经销商/省**：众数冲突时的优先级（如按最近业务月、按销量最大 BU）。 +2. **City 维度**：主策略提及 City，可在二期将投诉经入院量映射到 **City** 复用 MKT-RG-201 公式。 +3. **时间窗**：营销看板是否仅看「近 12 个月 C3登记」与入院同期对齐，需与质量方向默认窗一致或可配置。 +4. **操作不当同义词**：培训不足、使用错误等是否合并入「操作不当」码表。 + +--- + +*文档版本：与主策略 §4 及 `#数据与表结构.md` 字段对齐；前端演示见 `analytics-demo-web` 营销方向菜单。* diff --git a/分析策略/贝朗医疗数据分析策略.md b/分析策略/贝朗医疗数据分析策略.md new file mode 100644 index 0000000..2357349 --- /dev/null +++ b/分析策略/贝朗医疗数据分析策略.md @@ -0,0 +1,265 @@ +# 贝朗医疗数据分析策略 + +## 1 策略结构总览 + +- 从合规、质量、营销角度进行分析，探索数据背后的“故事”； +- 基于分析形成一些画像： + a. “投诉行为” + b. “投诉人” +- 未来当收到一个新的投诉报告时，将会与画像匹配，以推动后续的处理过程更高效、准确、控制风险。 + + +## 2 合规方向：药物警戒监管分析 + +> 目标：满足中国医疗器械不良事件监测法规要求，确保合规上报、趋势预警，支撑定期风险评估报告。 + +适用于药物警戒/器械警戒部门。 + +> **指标落地文档**：[合规方向分析.md](./合规方向分析.md)（各分析主题的指标编码、计算逻辑/方法与页面呈现用途说明）。 + +### 2.1 用于监管报告 + +#### 2.1.1 PSUR撰写（符合中国医疗器械 PSUR 报告要求） + +a. **总体趋势图** + - 年度/季度不良事件发生数趋势折线图 + - 各主要产品/注册证号的年度事件数变化 + +b. **发生率/PPM 走势图** + - 产品级不良事件发生率（百万分之事件率，PPM）趋势图 + - 按 BU/产品线分组的发生率控制图（SPC控制图） + +c. **器械故障类型与伤害表现分布表** + - TOP 10 器械故障类型分布柱状图 + - 各主要伤害表现（如出血、感染、空气栓塞等）频次表 + +d. **典型组合矩阵/热力图** + - 伤害表现 × 器械故障表现交叉热力图（字段、分层与监管对照等深化分析见 **5.1**） + +e. **严重不良事件（SAE）专项分析** + - 严重伤害或死亡事件年度/季度趋势图 + - 典型 SAEs 分布（按产品/医院/地区等维度） + +f. **分区域分布地图/表** + - 按省份/城市的不良事件发生率地图 + - 各区域 TOP 事件类型分布表 + +g. **投诉/不良事件上报时效性分析图** + - 上报时长分布箱线图/直方图（分 15天/45天等规限） + +h. **注册证号安全档案表（产品安全一览）** + - 以注册证号为维度，汇总不良事件数、投诉数、发生率、严重事件占比、主要故障表现 + - 关联字段：不良事件.注册证编号、投诉.注册证号 + - 产出：每个注册证号的“安全性概况”一览；识别需重点监测或再评价的注册证 + - 合规价值：对接 PSUR 与注册证维护、再评价要求 + +i. **补充说明类** + - 重点新产品上市后不良事件与发生率趋势对比图 + - CAPA（纠正和预防措施）执行后的不良事件变化趋势图（可选，若有整改措施） + +> 以上图/表建议结合主要产品线、监管重点，以及年度/季度时序变化展示，覆盖 PSUR 报告“总体趋势”、“主要风险”、“区域分布”、“常见原因”、“严重事件”等核心章节需求。 + +### 2.2 合规行为分析 + +#### 2.2.1 不良事件上报合规性审计 + +- **分析内容**：以投诉表的"是否不良事件=是"的记录为基准，验证是否每一条都能在不良事件表中找到对应记录（通过 医院+产品+型号+时间窗口 进行匹配） +- **关联字段**：投诉.医院名称 → 不良事件.单位名称 | 投诉.产品名称 → 不良事件.产品名称 | 投诉.C3登记日期 → 不良事件.审核日期 +- **分析产出**： + - 漏报率（投诉标记为不良事件但在 AE 表中找不到对应记录） + - 上报时效（C3登记日期 vs 审核日期的时间差是否符合 15 天/紧急/45 天报告时限） +- **合规价值**：直接回应 NMPA《医疗器械不良事件监测和再评价管理办法》中的上报义务 + +## 3 质量方向：产品质量提升分析 + +> 目标：通过数据驱动发现产品质量薄弱环节，指导 CAPA（纠正预防措施），提升产品可靠性。 + +> **指标落地文档**：[质量方向分析.md](./质量方向分析.md)（质量方向三层监测：批次溯源、产品/故障模式、趋势与升级路径；含指标编码、计算逻辑与页面用途）。 + +### 3.1 投诉集中性分析 + +基于质量投诉表。 + +a. 质量投诉的批号集中 +b. 质量投诉的医院集中性 +c. 质量投诉的产品集中性 +d. 质量投诉的事件集中性 + +**e. 产品 × 故障类型 Pareto 分析** + +- **分析内容**：对投诉数据按 **产品 × 故障类型** 进行 Pareto（二八）分析 +- **关联字段**：投诉.产品名称 × 投诉.故障类型 +- **分析产出**： + - 各产品 Top 3 故障类型及占比 + - 全局 Pareto 图：哪些产品-故障组合贡献了 80% 的投诉量 + - 聚焦 "渗漏""断裂""流速异常" 等高频故障的深层原因 +- **质量价值**：指导质量改进优先级——把资源集中在贡献最大的缺陷类型上 + +**f. 批号维度的集中性** + +- **分析内容**：按批号统计投诉数量和不良事件数量，识别"问题批次" +- **关联字段**：投诉.批号、不良事件.产品批号 +- **分析产出**： + - 单批次投诉集中度分析（同一批号出现多次投诉） + - 问题批次的故障类型集中度 +- **质量价值**：辅助生产过程质量回溯，触发批次调查 + +### 3.2 趋势分析 + +a. 首次出现报告的医院 +b. 首次出现报告的产品 +c. 过去一段时间内报告数量增长超过 20% 的产品 +d. 过去一段时间内报告数量增长超过 20% 的区域 +e. 批号维度的趋势：与上月对比，增长趋势超过 20% 的批号 +f. 批号时间分布：是否某些时间段生产的批次质量波动更大 + +### 3.3 投诉行为分析 + +a. 按医院投诉量与销售量关系 + +b. 按医院投诉量与首次入院时间的关系（新市场 / 新入院产品的投诉预警） + +- **分析内容**：利用入院量数据中的 LY Qty（去年数量）字段，识别新入院（去年销量为 0）的产品-医院组合，关联其投诉发生率 +- **关联字段**：入院量（LY Qty=0 的记录 → HospitalName、MaterialDesc）× 投诉（医院名称、产品名称） +- **分析产出**： + - 新入院产品组合列表 + - 新入院 vs 存量产品的投诉率对比 + - 新入院后首次投诉的时间分析——是否在入院初期投诉集中 +- **营销价值**：为新产品入院制定标准化的培训与跟进计划，减少磨合期投诉 + +c. 医院投诉热点与销售增长的关联分析 + +- **分析内容**：分析投诉集中的医院，其销售增长趋势是否受到影响 +- **关联字段**：投诉（医院、时间）× 入院量（HospitalName、Growth% Amt、Growth% Qty） +- **分析产出**： + - 高投诉医院的销售增长率 vs 低投诉医院的销售增长率对比 + - 投诉率高的医院是否出现采购量下滑信号 + - 投诉后的销量变化趋势（投诉发生后 3-6 个月的入院量变化） +- **营销价值**：量化投诉对客户关系和业务的影响，驱动客户关系修复 + +d. 投诉行为与处理结果的关系：是否赔偿与投诉动因关联 + +**e. 调查结论与产品/故障类型关系** + +- **分析内容**：分析投诉调查结论的分布及其与产品、故障类型的关系 +- **关联字段**：投诉.调查结论 × 投诉.产品名称 × 投诉.故障类型 +- **分析产出**： + - 调查结论分布：产品缺陷成立 vs 未复现 vs 操作不当 vs 运输损伤 vs 资料不足 + - **"产品缺陷成立"** 的投诉进一步按产品和故障类型细分，作为确认的质量问题池 + - **"操作不当"** 的投诉识别培训需求 + - **"运输损伤"** 的投诉识别供应链薄弱环节 + - **"资料不足"** 的投诉审视样品返回与信息收集流程的改进空间 +- **质量价值**：将模糊的"投诉"转化为分类明确的"质量改进项" + +**f. 投诉处理成本分析** + +- **分析内容**：分析赔付结论的分布及与产品、故障类型的关系 +- **关联字段**：投诉.赔付结论 × 投诉.产品名称 × 投诉.调查结论 +- **分析产出**： + - 各赔付类型（换货/折让/退款/无赔付/其他）占比 + - "产品缺陷成立"结论下赔付方式分布 + - 按产品的赔付频率排名——质量成本最高的产品 +- **质量价值**：量化质量失败成本（COQ），驱动管理层投入改进资源 + +g. 高增长产品的质量风险前置预警（增长率与投诉率联动） +h. 投诉关闭后重复投诉率（同医院同产品）分析 +i. 故障类型“首发时间”与“集中爆发时间”窗口识别 +j. CY LE AMT 与投诉率偏差分析（销量预估与质量压力） +k. 样品返回数量与“产品缺陷成立”概率关系分析 +l. 故障类型与赔付方式联动矩阵分析 +m. 同产品不同型号的质量稳定性排名 +n. 运输损伤类投诉在不同经销商间差异对比 +o. 资料不足类投诉的信息缺口画像（缺失字段模式） +p. 投诉联系人角色（护士/工程师/设备科）与故障类型偏好分析 +q. 多故障并发表现识别（同条投诉多症状共现） +r. 投诉发生时间与法定节假日/医疗高峰期（如春节、国庆、住院高峰）关联分析 +s. 投诉描述文本中的潜在“批次/供应链异常”信号自动识别 +t. 历史投诉中“同产品同批次”发生多起投诉的聚类与溯源分析 +u. 投诉归口及流转效率分析——多节点审批/结案周期分布特征 +v. 投诉中客户反馈新需求/改进建议的文本挖掘与分类 +w. 投诉中的“医生/护士/患者”三方主诉分析，识别核心痛点归属 +x. 投诉样本照片/附件的结构化分析（如照片缺失率、图片内容自动标签） +y. 同一医院内多品牌产品的投诉率交叉对比，识别品牌优势与短板 + +### 3.4 AE报告行为分析 + +#### 3.4.1 AE报告原因推测 + +a. 按医院报告量与销售量关系 +b. 按医院报告量与首次入院时间的关系 +c. 医院 AE 报告热点与销售增长的关联分析 +d. 医院报告与处理结果的关系：是否赔偿与报告动因关联 +e. 医院报告时间习惯分析：是否年底（如是，打上标签：为满足任务） +f. 不同事业线不良事件升级率对比（投诉合并不良事件的概率） +g. 不良事件与样品返回比例的相关性分析（证据链完整性） + +#### 3.4.2 报告而不发起投诉原因分析 + +a. 事件名称 +b. 事件结局 +c. 报告时间 +d. 医院、区域 + +#### 3.4.3 报告且同时投诉事件分析 + +a. 事件名称 +b. 事件结局 +c. 调查原因 + +## 4 营销方向：市场沟通与推广分析 + +> 目标：从投诉和不良事件数据中发现可能由营销（使用培训不到位、推广方式、客户沟通）等因素导致的问题，反哺营销策略优化。 + +> **指标落地文档**：[营销方向分析.md](./营销方向分析.md)（MKT-OP / MKT-RG 指标编码、计算逻辑与页面呈现用途）。 + +### 4.1 操作不当与投诉 + +- **分析内容**：聚焦调查结论为 **"操作不当"** 的投诉，分析其在不同医院、不同经销商覆盖区域的分布 +- **关联字段**：投诉（调查结论=操作不当、医院名称）× 入院量（HospitalName、DealerName、Province） +- **分析产出**： + - 操作不当投诉的医院分布——哪些医院使用培训可能不到位 + - 通过入院量表关联经销商，识别哪些经销商区域操作不当投诉率较高 + - 操作不当投诉占比高的产品，可能存在产品使用说明不清晰或培训支持不足 +- **营销价值**：定向加强培训支持，优化产品操作培训材料，指导经销商管理 + +### 4.2 区域与经销商维度的投诉率比较 + +- **分析内容**：通过入院量数据中的省份和经销商信息，将投诉数据映射到区域和经销商维度 +- **关联字段**：投诉.医院名称 → 入院量.Province / City / DealerName +- **分析产出**： + - 各省份投诉率排名（投诉数/入院量） + - 各经销商覆盖区域的投诉率排名 + - 识别投诉率异常高的区域——可能存在经销商储运不当或客户支持不足 +- **营销价值**：优化渠道管理，对高投诉率经销商进行专项辅导或考核 + +## 5 事件实质分析 + +### 5.1 伤害表现与器械故障的关联矩阵 + +- **分析内容**：构建 **伤害表现 × 器械故障表现** 的交叉矩阵（热力图），识别高频的伤害-故障组合；与 2.1.1 d 为同一分析主线，本节给出完整字段与产出口径 +- **关联字段**：不良事件.伤害表现 × 不良事件.器械故障表现 +- **分析产出**： + - 哪些器械故障最容易导致严重伤害 + - 按产品分层后，各产品的典型故障-伤害模式 + - 对照监管关注的伤害类型（感染、出血、空气栓塞等）进行重点标注 +- **合规价值**：为不良事件风险评估提供量化依据，支撑 CAPA 优先级排序 + +### 5.2 故障类型季节性分析 + +高温/潮湿季节是否更易渗漏或包装问题等季节性模式分析。 + +## 6 安全维度客户画像 + +> 与跨维度结论汇总的衔接见 [综合分析.md](./综合分析.md) §1.2（§6 画像能力预留说明）。 + +- 高投诉但高复购医院的客户忠诚画像分析 +- 投诉赔付方式对后续采购增长的影响分析 + +## 7 综合联动分析 + +> **指标与结论文档**：[综合分析.md](./综合分析.md)（跨维度图表结论列表汇总、与 §6 画像扩展说明）。 + +- 构建“事件严重度-业务影响度”双轴优先级矩阵 +- 构建“医院分层经营策略”建议（高风险治理型/高潜力增长型） +- 构建“质量成本-业务收益”平衡模型（赔付、退换、增长） +- 构建“监管风险热区地图”（按产品、区域、时间） diff --git a/分析策略/质量方向分析.md b/分析策略/质量方向分析.md new file mode 100644 index 0000000..8876d40 --- /dev/null +++ b/分析策略/质量方向分析.md @@ -0,0 +1,195 @@ +# 质量方向分析（落地说明） + +> 本文档由《贝朗医疗数据分析策略》**质量维度**拆分而来，面向质量、工程、供应链与 CAPA 负责人，用于指标口径统一、开发实现与页面文案设计。 +> 「质量方向」三层监测链路指：**批次溯源 → 产品与故障模式监测 → 趋势与行为预警**，将投诉与（必要时）不良事件、入院量联动，支撑缺陷优先级、批次调查与改进闭环。 +> 合规维度见 [合规方向分析.md](./合规方向分析.md)；营销维度见 [营销方向分析.md](./营销方向分析.md)（主策略 §4）。 + +指标文档化要素（业务定义、可计算定义、维度、过滤、数据源、实现注意点、输出形态、页面用途）建议与 [合规方向分析.md](./合规方向分析.md) **§0** 保持一致，下文各表按「分析主题 → 指标清单」展开。 + +--- + +## 1 策略定位与数据范围 + +### 1.1 业务目标 + +通过数据驱动识别**产品质量薄弱环节**与**过程异常**（批号、产线、医院聚集等），指导 **CAPA** 与资源投入；输出可下钻至单条投诉/单批次的清单与趋势，并与（可选）不良事件交叉验证「市场反馈—监管报告」一致性。 + +### 1.2 适用对象 + +质量部、产品安全/可靠性工程、生产与供应链质量、医学事务（根因评审）、必要时联合 PV/合规做升级与漏报核对。 + +### 1.3 主数据对象 + +| 对象 | 典型用途 | +|------|----------| +| **质量投诉表** | 批号/医院/产品/故障类型集中性、调查结论与赔付、处理周期、重复投诉 | +| **入院量表** | 投诉率分母（CY Qty / CY Amt 等）、新入院识别（LY Qty）、区域与经销商映射、销量增长 | +| **不良事件表** | 批号维度与投诉/AE 双计数、升级路径佐证、与合规文档中矩阵类分析衔接 | + +字段级清单与三表关联见工作区 `#数据与表结构.md`。 + +### 1.4 已定口径（全局默认，可与合规文档对齐） + +以下适用于本文件全部指标，除非单条指标标注「例外」。 + +| 项目 | 建议口径 | +|------|----------| +| **投诉主时间轴** | 以 **`C3登记日期`** 作为趋势、集中性、率类指标的默认时间过滤字段；结案效率类指标可并列使用 **`关闭日期`** / **`调查报告完成日期`**，并在 UI 脚注区分。 | +| **投诉统计单元** | **投诉条数**（以 **`C3编号`** 唯一；同屏不混用「例数」汇总除非单独定义）。 | +| **集中性分析的有效集合** | 默认排除测试数据（若有标记字段）；**投诉状态**可按业务选择「含调查中」或「仅已关闭」，全公司一致并在报表声明。 | +| **投诉率分母** | 与入院量关联时，分母为同期、与投诉在 **医院 + 产品（或物料）** 对齐键上汇总的 **CY Qty 或 CY Amt**（二选一固化，与合规侧 PPM 分母策略协调，避免同一管理层看板两套分母字段）。 | +| **新入院组合** | 入院量表中 **`LY Qty = 0`** 且当年 **`CY Qty > 0`** 的 **HospitalName + MaterialDesc（或产品名称映射）** 记为「新入院产品-医院组合」；与策略 §3.3 b 一致。 | +| **环比增长阈值** | 策略原文「增长超过 20%」落地为：`(当期计数 − 对比期计数) / NULLIF(对比期计数, 0) ≥ 0.2`；**对比期**默认取「等长上一时间窗」（如本月 vs 上月、本季 vs 上季），可配置为同比。 | + +**不良事件在质量方向分析中的角色**：用于 **批号双源对照**、**升级率** 及与合规侧 **伤害×故障矩阵**（见合规文档 §2.4 / 主策略 §5.1）的叙事衔接；AE 主时间轴仍以合规文件 §1.4 为准（**发生日期**），与投诉的 **C3登记日期** 混用须在页面标注双时间轴。 + +--- + +## 2 层级一：批次与供应链溯源 + +### 2.1 主题 A：批号集中与「问题批次」识别 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-BTH-101** | 批号投诉条数排名 | 按 **`批号`**（投诉表）分组，在 **`C3登记日期`** 落入统计期的集合内对 **投诉条数** 计数，降序取 TopN。空批号可单列「未填批号」桶。 | **条形图 + 下钻清单**：快速锁定高频问题批，触发批次调查流程。 | +| **QLT-BTH-102** | 单批重复投诉率 | 对每条非空批号：`该批投诉条数 / 该批涉及医院去重数` 或 `该批投诉条数 / 该批产品入院量（若可对齐）`；二选一全司固化。**简单版**：批内投诉条数 ≥2 记为「重复投诉批次」并列表。 | **批次风险标签**：区分「单次孤立」与「同批多点爆发」。 | +| **QLT-BTH-103** | 问题批次故障结构 | 在 QLT-BTH-101 选中的批号子集上，对 **`故障类型`** 计数及占比。 | **堆叠条或饼图**：支撑根因假设（工艺 vs 运输 vs 原料）。 | +| **QLT-BTH-104** | 投诉批号 × AE 产品批号双计数 | 同一统计期内：投诉侧按 **`批号`** 计数；AE 侧按 **`产品批号`** 计数。通过 **产品名称（及可选型号）** 弱关联后并列展示（不要求逐条匹配）。 | **对照表**：质量与 PV 共看「同一产品批是否双通道上升」。 | + +--- + +### 2.2 主题 B：批号趋势与生产时段波动 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-BTH-201** | 批号投诉量环比增速 | 按批号聚合 **`C3登记日期`** 落入「本月」与「上月」的投诉条数，计算环比增速；筛选增速 **≥20%**（见 §1.4）的批号列表。 | **预警列表**：优先列入周质量例会。 | +| **QLT-BTH-202** | 批号首诉至峰值间隔 | 对每一批号：`首条 C3登记日期` 与 `该批投诉条数达峰月份` 的间隔（天/周）。 | **过程能力参考**：评估从露头到爆发的响应窗口是否足够。 | +| **QLT-BTH-203** | 生产/入库时段与批号质量波动（探索性） | 若有 **`批号→生产日期`** 映射表则按生产周/月聚合投诉条数；否则用 **C3登记月** 作为代理时间轴对高投诉批号聚类。**注意**：代理轴与真实生产周混淆风险须在脚注说明。 | **季节/产线波动图**：与主策略 §5.2「故障季节性」联动时，优先在 **故障类型 × 月份** 上复用同一套时间桶。 | + +--- + +## 3 层级二：产品与故障模式（集中性与根因池） + +### 3.1 主题 C：多维集中性（批号 / 医院 / 产品 / 事件） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-CNC-301** | 医院投诉集中度（HHI 或 TopN 占比） | 按 **`医院名称`** 计数投诉条数；可计算 **HHI** = Σ(份额²) 或 **Top5 医院占比**。时间过滤：**`C3登记日期`**。 | **地图/条形图**：识别「单点高压」医院，安排现场或培训。 | +| **QLT-CNC-302** | 产品投诉集中度 | 按 **`产品名称`**（或映射到 **MaterialDesc**）计数；可叠加 **BU** 分层。 | **Pareto 条形图**：与 QLT-PRD 系列共用产品排序逻辑。 | +| **QLT-CNC-303** | 事件/故障类型集中度 | 按 **`故障类型`** 或从 **`投诉详情`** 抽取的事件标签（若后续有 NLP）计数；Top10 及累计占比达 80% 的截断线（Pareto）。 | **全局缺陷雷达**：与 §3.2 主题 E 的「产品×故障」互补（一维 vs 二维）。 | + +--- + +### 3.2 主题 D：产品 × 故障类型 Pareto（二八分析） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-PRD-401** | 组合键投诉条数 | 维度 = **`产品名称` × `故障类型`**，统计期内对 **投诉条数** 求和；按条数降序。 | **Pareto 图（横轴为组合）**：展示「80% 投诉由哪些组合贡献」。 | +| **QLT-PRD-402** | 各产品 Top3 故障类型及占比 | 在每个 **`产品名称`** 内，对 **`故障类型`** 取 Top3，占比 = 该类型条数 / 该产品总投诉条数。 | **产品卡片矩阵**：研发与工程按产品认领改进项。 | +| **QLT-PRD-403** | 高频故障聚焦清单 | 在全局或 BU 子集上，筛选 **`故障类型`** ∈ {渗漏, 断裂, 流速异常, …}（码表可配置）且条数超阈值的组合。 | **CAPA 输入池**：与主策略 §3.1 e 示例故障对齐。 | + +--- + +### 3.3 主题 E：调查结论与质量改进项池 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-INV-501** | 调查结论分布 | 对 **`调查结论（处理结果）`** 计数及占比（产品缺陷成立 / 未复现 / 操作不当 / 运输损伤 / 资料不足等）。时间：**`C3登记日期`** 或 **`调查报告完成日期`**（二选一做「调查产出」视图时固定）。 | **堆叠柱（按时间）**：看结论结构是否恶化（如「产品缺陷成立」上升）。 | +| **QLT-INV-502** | 「产品缺陷成立」× 产品 × 故障 | 子集：`调查结论` = **产品缺陷成立**；按 **产品 × 故障类型** 计数。 | **已确认质量问题池**：DFMEA/PFMEA 与设计变更的输入。 | +| **QLT-INV-503** | 「操作不当」× 医院 / 产品 | 子集：`调查结论` = **操作不当**；按医院或产品聚合。 | **培训需求清单**：与营销 §4.1 可共用数据，页面受众不同。 | +| **QLT-INV-504** | 「运输损伤」× 经销商（若可关联） | 子集：`调查结论` = **运输损伤**；通过入院量 **`DealerName`** 与投诉医院映射后聚合。 | **物流薄弱环节看板**：与主策略 §3.3 n 一致方向。 | +| **QLT-INV-505** | 「资料不足」字段缺失模式 | 统计「资料不足」子集中 **`有样品返回`**、附件、关键文本为空等模式（字段可用时）。 | **流程 IT 改进**：减少反复补件。 | + +--- + +### 3.4 主题 F：质量失败成本（赔付与产品） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-CST-601** | 赔付方式分布 | 对 **`赔付结论`**（换货/折让/退款/无赔付/其他）计数及占比。 | **COQ 概览卡片**：管理层看质量失败外显成本结构。 | +| **QLT-CST-602** | 产品缺陷成立下的赔付结构 | 在 QLT-INV-502 同子集上交叉 **`赔付结论`**。 | **条形堆叠**：识别「高赔付+高缺陷成立」产品。 | +| **QLT-CST-603** | 按产品的赔付频次排名 | 按 **`产品名称`** 统计「非无赔付」条数或加权分数（若金额字段未来接入则替换为金额）。 | **质量成本最高产品榜**：资源分配与退市/改版讨论依据。 | + +--- + +## 4 层级三：趋势、行为与升级路径 + +### 4.1 主题 G：首次报告与增长预警 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-TRN-701** | 首次出现投诉的医院 | 对每个 **`医院名称`**，取 **最小 `C3登记日期`** 落在统计期内且该医院历史（全量或滚动三年）此前无投诉则标记「首诉医院」。 | **新风险点清单**：客户成功或质量拜访优先级。 | +| **QLT-TRN-702** | 首次出现投诉的产品 | 同理对 **`产品名称`**（或物料）判定「首诉产品」。 | **新产品/新适应症暴露** 监测。 | +| **QLT-TRN-703** | 产品投诉量环比增长超 20% | 产品维度下对比 **等长两窗** 投诉条数，增速公式见 §1.4；输出超阈产品列表。 | **趋势预警表**：与主策略 §3.2 c 一致。 | +| **QLT-TRN-704** | 区域（省）投诉量环比增长超 20% | 投诉经医院映射 **`Province`**（入院量）后聚合；环比同 §1.4。 | **区域热力 + 列表**：供应链或渠道协同。 | + +--- + +### 4.2 主题 H：投诉关闭与重复投诉 + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-RPT-801** | 同医院同产品重复投诉率 | 定义「重复」：`医院名称 + 产品名称` 在 **`关闭日期`** 后再次 **`C3登记日期`** 的新投诉（窗口如 90/180 天可配置）。**重复率** = 重复组合数 / 有关闭记录的组合数（定义需版本化）。 | **闭环有效性 KPI**：CAPA 是否真正止血。 | +| **QLT-RPT-802** | 投诉关闭周期分布 | `关闭日期 − C3登记日期`（天），在已关闭子集上直方图/箱线图。 | **流程效率**：与主策略 §3.3 u 方向一致。 | + +--- + +### 4.3 主题 I：入院量联动的质量信号（投诉率与新入院） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-SAL-901** | 医院×产品投诉率 | **分子**：统计期内该 **医院+产品** 投诉条数（**`C3登记日期`**）。**分母**：同期入院量 **CY Qty**（或 Amt）在相同对齐键上汇总。无分母时灰显。 | **散点或四象限**：识别「低销量高投诉」异常点。 | +| **QLT-SAL-902** | 新入院组合投诉率 vs 存量 | 新入院定义见 §1.4；分别计算新入院组合与存量的 **投诉率**（分子分母同 QLT-SAL-901）。 | **新市场磨合风险**：与主策略 §3.3 b 营销价值并列展示时脚注受众。 | +| **QLT-SAL-903** | 新入院后首诉时间 | 对每个新入院组合，首条投诉的 **`C3登记日期`** 与入院首月的间隔分布。 | **入院后 30/60/90 天** 关怀与巡检依据。 | + +--- + +### 4.4 主题 J：AE 升级与证据链（与合规衔接） + +| 指标编码 | 指标名称 | 计算逻辑与方法 | 页面呈现用途 | +|----------|----------|----------------|--------------| +| **QLT-AE-1001** | 投诉合并为不良事件比例（升级率） | **`是否不良事件 = 是`** 的投诉条数 / 总投诉条数（时间窗内）；可按 **BU** 分层。 | **升级文化/流程** 对比：各事业线是否愿报、敢报。 | +| **QLT-AE-1002** | 样品返回与调查结论关系 | 交叉 **`有样品返回`** / **`上报坏品数量`** 与 **`调查结论`**（卡方或简单占比表）。 | **证据链完整性**：与主策略 §3.4.1 g 一致。 | +| **QLT-AE-1003** | 医院 AE 报告量 vs 入院量 | AE 按 **`单位名称`** 与 **发生日期**（合规口径）计数；入院量同院同期分母；散点。**注意**：与投诉率时间轴不同，页面须双脚注。 | **报告行为异常点**（非直接质量结论）：识别需复核的报送模式。 | + +**漏报与上报时效**：严格合规 KPI 仍以 [合规方向分析.md](./合规方向分析.md) **§3.1**（`CMP-CV-101`～`104` 等）为准；质量方向分析视图可 **嵌入同一语义指标** 或链接跳转，避免重复定义。 + +--- + +## 5 扩展分析主题（指标池与优先级建议） + +主策略 §3.3 中 **g–y**、§3.4.2、§3.4.3、§5.2 等属于**深化与探索**能力，建议按价值—难度矩阵分期： + +| 分期 | 主题摘要 | 说明 | +|------|----------|------| +| **一期** | 高增长产品投诉联动、重复投诉、关闭周期、文本关键词规则（批次/供应链信号） | 与现有字段强相关，易验收。 | +| **二期** | 故障首发/爆发窗口、CY LE AMT 偏差、多故障并发、经销商运输对比 | 需更多时间窗配置或统计规则。 | +| **三期** | 投诉描述 NLP、附件/照片结构化、跨品牌医院对比 | 依赖模型与外部数据。 | + +**季节性（主策略 §5.2）**：建议落地为 **`故障类型` × `月份`** 的投诉条数热力图，时间轴用 **`C3登记月份`**；与 **QLT-BTH-203** 共用月份维度以便对照。 + +--- + +## 6 与主策略文档的对应关系 + +| 主策略章节 | 本文档章节 | +|------------|------------| +| §3.1 投诉集中性（含 Pareto、批号与 AE） | §2.1、§3.1–§3.2 | +| §3.2 趋势分析 | §2.2、§4.1 | +| §3.3 投诉行为（调查结论、成本、重复投诉等） | §3.3–§3.4、§4.2、§4.3；营销侧重条目见主策略 §4 | +| §3.4 AE 报告行为（与质量方向交叉部分） | §4.4 | +| §5.2 故障类型季节性 | §5 扩展分期说明 | + +--- + +## 7 仍建议在数据模型层固化的细节 + +1. **投诉 ↔ 入院量产品对齐键**：`产品名称` 精确匹配 vs **MaterialDesc** 映射表；未匹配入桶规则。 +2. **批号为空率**与是否强制校验（影响 QLT-BTH-* 覆盖率）。 +3. **`调查结论`、`赔付结论`** 码表与中英文口径统一（ETL 清洗规则版本化）。 +4. **重复投诉** 的时间窗与「同一条重开」业务规则（是否算 1 条还是 2 条）。 +5. **QLT-AE-1003** 与合规侧 AE 统计单元（报告条数）一致，避免与投诉条数混读。 + +--- + +*文档版本：与主策略 §3 质量方向及 `#数据与表结构.md` 字段对齐；前端演示见 `analytics-demo-web` 质量方向与事件实质菜单；具体数仓表名与刷新 SLA 可另页维护。* diff --git a/前端技术设计规范.md b/前端技术设计规范.md new file mode 100644 index 0000000..2ba4f9a --- /dev/null +++ b/前端技术设计规范.md @@ -0,0 +1,1968 @@ +# 前端技术设计规范 + +## 目录 +1. [项目概述](#项目概述) +2. [技术栈](#技术栈) +3. [项目架构](#项目架构) +4. [页面结构规范](#页面结构规范) +5. [组件使用规范](#组件使用规范) +6. [业务组件规范](#业务组件规范) +7. [图标使用规范](#图标使用规范) +8. [样式规范](#样式规范) +9. [文件预览规范](#文件预览规范) +10. [路由规范](#路由规范) +11. [状态管理规范](#状态管理规范) +12. [接口处理规范](#接口处理规范) +13. [最佳实践](#最佳实践) + +## 项目概述 + +本项目是一个企业智能运营管理系统（Smart Ops Front），采用 Vue 3 + Vite + Element Plus 技术栈构建，提供完整的权限管理、知识库管理、CRM管理、OA审批等功能模块。 + +### 设计原则 +- **统一性**：所有页面采用相同的布局结构和交互模式 +- **简洁性**：基于Element Plus组件库，避免重度定制样式 +- **可维护性**：使用composable模式和组件分离提高代码质量 +- **可扩展性**：模块化设计，支持功能快速迭代 + +## 技术栈 + +### 核心框架 +- **Vue 3.3.4** - 渐进式JavaScript框架 +- **Vite 4.4.9** - 下一代前端构建工具 +- **Vue Router 4.2.4** - 官方路由管理器 +- **Pinia 2.1.6** - Vue状态管理库 + +### UI组件库 +- **Element Plus 2.10.4** - 基于Vue 3的组件库 +- **@element-plus/icons-vue 2.1.0** - Element Plus图标库 + +### 表格组件 +- **vxe-table 4.14.1** - 高性能表格组件 +- **xe-utils 3.7.6** - 表格工具库 + +### 编辑器组件 +- **@umoteam/editor 7.0.1** - 富文本编辑器 +- **@vueup/vue-quill 1.2.0** - Quill编辑器Vue组件 +- **@vue-office/** - Office文档预览组件 + +### 工具库 +- **@vueuse/core 13.1.0** - Vue组合式API工具集 +- **axios 1.5.0** - HTTP客户端 +- **crypto-js 4.2.0** - 加密库 +- **echarts 5.6.0** - 数据可视化图表库 + +## 项目架构 + +### 目录结构 +``` +src/ +├── api/ # API接口层 +├── assets/ # 静态资源 +│ ├── images/ # 图片资源 +│ └── styles/ # 样式文件 +│ ├── index.scss # 主样式文件（设计令牌） +│ └── common.scss # 公共页面样式 +├── components/ # 公共组件 +├── composables/ # 组合式函数 +├── layout/ # 布局组件 +├── router/ # 路由配置 +├── stores/ # 状态管理 +├── utils/ # 工具函数 +└── views/ # 页面组件 + ├── account/ # 账户管理 + ├── crm/ # CRM管理 + ├── knowledge/ # 知识库管理 + ├── oa-approval/ # OA审批 + ├── org/ # 组织管理 + └── system/ # 系统管理 +``` + +### 架构特点 +- **分层架构**: API层、组件层、页面层清晰分离 +- **模块化设计**: 按业务功能模块组织代码 +- **组件化开发**: 可复用的公共组件和业务组件 +- **状态管理**: 使用Pinia进行全局状态管理 +- **Composable模式**: 使用composable函数实现逻辑复用 +- **动态组件**: 支持按需加载和动态组件管理 + +## 页面结构规范 + +### 1. 页面容器规范 + +#### 必须使用 PageContainer 包裹 +所有页面必须使用 `PageContainer` 组件作为根容器： + +```vue + + + +``` + +### 2. 标准页面结构 + +#### 普通列表页面结构 +```vue + +``` + +#### 一级菜单首页结构（模块Dashboard） +**重要说明**：一级菜单的首页（如 `/email`、`/crm`、`/knowledge` 等路由的根页面）必须采用特殊的模块首页布局，不能使用普通列表页面结构： + +**标准首页结构（带动画效果）** - **推荐使用**： +```vue + + + +``` + +**简化首页结构（无动画效果）**： +```vue + +``` + +**关键区别**： +- **模块首页**：使用 `
` 直接包裹内容区域 +- **普通列表页**：使用 `` 包裹内容区域 + +**样式选择**： +- **`module-home-header`**：华丽的动画效果，适合重要的模块首页（推荐） +- **`page-header`**：简洁的渐变样式，适合功能型页面或简化的首页 + +**类名对照表**： +| 用途 | 类名 | 说明 | +|------|------|------| +| 模块首页容器 | `module-dashboard-container` | 统一的模块首页容器 | +| 动画头部 | `module-home-header` | 带背景动画的头部样式 | +| 简化头部 | `page-header` | 简洁的渐变头部样式 | +| 模块图片 | `module-image` | 模块banner图片容器 | +| 文字内容 | `header-text` | 头部文字内容区域 | +| 状态指示器 | `status-indicator` | 系统状态显示 | + +**应用场景**： +- **模块首页**：如 `/email`、`/crm`、`/knowledge` 等一级菜单的入口页面 +- **普通列表页**：如 `/email/management`、`/crm/customer`、`/knowledge/repository` 等功能页面 + +**识别规则**： +1. **路由层级**：一级菜单的根路由页面（如 `/email/index/Dashboard.vue`） +2. **页面性质**：展示模块概览、统计数据、功能入口的首页 +3. **文件位置**：通常位于 `views/模块名/index/Dashboard.vue` 或 `views/模块名/Dashboard.vue` +4. **菜单结构**：在左侧菜单中作为一级菜单的主页面 + +**样式文件优化**： +- ✅ **统一封装**：所有首页样式都在 `src/assets/styles/common.scss` 中定义 +- ✅ **完整动画**：包含流星漂移、浮动形状、呼吸状态指示器等动画效果 +- ✅ **响应式设计**：自动适配移动端和桌面端 +- ✅ **模块特定样式**：各模块只需要在自己的文件中添加特定样式 +- ✅ **性能优化**：避免重复代码，减少CSS体积 + +**使用指南**： +1. **导入样式**：在Vue文件中使用 `@import '@/assets/styles/common.scss'` +2. **统一结构**：使用标准的模板结构和类名 +3. **内容区域**：使用 `.module-content` 包裹所有模块内容 +4. **首页布局**：在 `.module-content` 内使用 `.dashboard-layout` 进行布局 +5. **模块特定样式**：在模块的style中添加特定的内容样式 +6. **图片资源**：将模块banner图片放在 `src/assets/images/模块名/banner.png` + +**正确的首页布局结构**： +```vue + +``` + +**层级说明**： +- `module-dashboard-container`：模块首页的根容器 +- `module-home-header`：带动画效果的模块头部 +- `module-content`：模块内容区域（所有模块页面的标准容器） +- `dashboard-layout`：首页专用的布局容器（只在Dashboard页面使用） +- `dashboard-row-1/2`：首页布局的行容器 + +**动画效果**： +- `meteor-drift`：流星漂移动画，3个不同延迟的流星在XY平面内移动 +- `float`：装饰形状的旋转和缩放动画（**已优化：移除上下浮动**） +- `pulse`：状态指示器的呼吸灯效果 +- **交互动画**：使用阴影、亮度、边框等效果替代Y轴位移 +- 所有动画都经过性能优化，使用硬件加速 + +**设计原则**： +- ❌ **禁止使用** `translateY` 进行上下浮动动画 +- ✅ **推荐使用** 阴影变化、颜色过渡、缩放、旋转等效果 +- ✅ **保持稳定** 所有元素位置固定，避免页面跳动 +- ✅ **流畅体验** 使用平滑的视觉反馈替代位移动画 + +### 动画设计规范 + +**推荐的悬停效果**： +```scss +// ✅ 推荐：使用阴影和亮度变化 +&:hover { + box-shadow: 0 8px 25px rgba(0, 0, 0, 0.15); + filter: brightness(1.05); + border-color: #primary-color; +} + +// ✅ 推荐：使用缩放和旋转 +&:hover { + transform: scale(1.05) rotate(2deg); + box-shadow: 0 4px 15px rgba(0, 0, 0, 0.1); +} + +// ❌ 禁止：使用Y轴位移 +&:hover { + transform: translateY(-5px); // 不要使用这种效果 +} +``` + +**装饰性动画原则**： +- 旋转动画：`transform: rotate(0deg to 360deg)` +- 缩放动画：`transform: scale(0.9 to 1.1)` +- 透明度变化：`opacity: 0.3 to 0.8` +- 颜色渐变：`background`, `border-color`, `color` 过渡 +- 禁止位移：避免 `translateX`, `translateY` 造成的位置跳动 + +### 快捷操作组件封装 + +**快捷操作区域**已在 `common.scss` 中统一封装，支持自适应布局和多种样式： + +```vue + +``` + +**自适应特性**： +- **最小宽度控制**：每个操作项最小宽度 `120px` +- **自动换行**：使用 `grid-template-columns: repeat(auto-fit, minmax(120px, 1fr))` +- **响应式布局**： + - 桌面端：最多8列 + - 平板端：自动适应 + - 手机端：最少2列，最小宽度100px + +**预设颜色系统**： +| 类名 | 颜色 | 图标渐变 | 悬停背景 | +|------|------|----------|----------| +| `color-0` | 蓝色 | `#6366f1 → #4f46e5` | 紫蓝色浅色 | +| `color-1` | 绿色 | `#10b981 → #059669` | 绿色浅色 | +| `color-2` | 橙色 | `#f59e0b → #d97706` | 橙色浅色 | +| `color-3` | 红色 | `#ef4444 → #dc2626` | 红色浅色 | +| `color-4` | 紫色 | `#8b5cf6 → #7c3aed` | 紫色浅色 | +| `color-5` | 青色 | `#06b6d4 → #0891b2` | 青色浅色 | +| `color-6` | 粉色 | `#ec4899 → #db2777` | 粉色浅色 | +| `color-7` | 草绿色 | `#84cc16 → #65a30d` | 草绿色浅色 | +| `color-8` | 灰色 | `#6b7280 → #4b5563` | 灰色浅色 | +| `color-9` | 深橙色 | `#f97316 → #ea580c` | 深橙色浅色 | + +**使用规则**： +- **顺序分配**：按照操作项的顺序依次使用 `color-0` 到 `color-9` +- **循环使用**：超过10个操作时，重新从 `color-0` 开始循环 +- **主要操作**：仍可使用 `primary-action` 类来突出显示最重要的操作 +- **视觉一致**：所有颜色都经过精心调配，确保视觉和谐 + +**布局规则**： +1. **网格优先**：优先显示更多列，到达最小宽度后自动换行 +2. **均匀分布**：使用 `1fr` 确保每项宽度相等 +3. **最小保证**：极小屏幕下确保至少显示2列 +4. **最大限制**：大屏幕下限制最大8列，避免过度拉伸 + +## 组件使用规范 + +### 1. 表格组件使用规范 + +#### 使用场景 +- **数据列表展示**: 用户列表、文件列表、订单列表等 +- **数据筛选排序**: 需要分页、搜索、排序的数据表格 +- **复杂数据操作**: 批量操作、行内编辑、树形数据等 + +#### 技术选型 +**必须使用 vxe-table 作为表格组件** + +```vue + + + + + + + +``` + +#### 表格配置规范 +```javascript +// 标准分页配置 +const pagerConfig = { + currentPage: 1, + pageSize: 20, + total: 0, + layouts: ['PrevPage', 'JumpNumber', 'NextPage', 'FullJump', 'Sizes', 'Total'] +} +``` + +### 2. 按钮组件使用规范 + +#### 按钮类型和使用场景 +```vue + + + + 确认 + + + + + + 取消 + + + + + + 删除 + + + + + + + + + + + 新增 + +``` + +### 3. 表单组件使用规范 + +```vue + + + + + + + + + + + + +``` + +### 4. 卡片组件使用规范 + +```vue + + + + + + + + + +``` + +### 5. 统计卡片组件规范 + +#### 统计卡片标准结构 +项目已在 `src/assets/styles/common.scss` 中封装了统一的统计卡片样式，支持多种布局和主题： + +```vue + + + +``` + +#### 布局类型 +| 类名 | 布局 | 响应式断点 | 使用场景 | +|------|------|------------|----------| +| `grid-4` | 4列布局 | 1200px→2列, 768px→1列 | 完整的统计面板 | +| `grid-3` | 3列布局 | 900px→2列, 768px→1列 | 知识库风格布局 | +| `grid-2` | 2列布局 | 768px→1列 | 简化的统计展示 | + +#### 主题颜色 +| 主题类名 | 颜色系 | 渐变色 | 适用场景 | +|----------|--------|--------|----------| +| `theme-blue` | 蓝色 | `#3b82f6 → #1d4ed8` | 主要数据、消息类 | +| `theme-red` | 红色 | `#ef4444 → #dc2626` | 紧急、警告类 | +| `theme-orange` | 橙色 | `#f59e0b → #d97706` | 待处理、提醒类 | +| `theme-green` | 绿色 | `#10b981 → #059669` | 完成、成功类 | +| `theme-purple` | 紫色 | `#a855f7 → #7c3aed` | 特殊、高级功能 | +| `theme-cyan` | 青色 | `#06b6d4 → #0891b2` | 活动、记录类 | +| `theme-pink` | 粉色 | `#ec4899 → #db2777` | 收藏、喜欢类 | +| `theme-lime` | 草绿 | `#84cc16 → #65a30d` | 新增、增长类 | + +#### CountUp数字动画组件 +统计卡片配合使用CountUp组件实现数字滚动动画效果： + +```vue + + + +``` + +#### 完整示例 +```vue + + + +``` + +#### 设计原则 +1. **视觉一致性**：所有统计卡片使用相同的尺寸和样式 +2. **颜色语义化**：根据数据类型选择合适的主题颜色 +3. **纯展示功能**：统计卡片仅用于数据展示，不支持点击交互 +4. **动画增强**：使用CountUp组件提升用户体验 +5. **响应式设计**：自动适配不同屏幕尺寸 +6. **悬浮反馈**：支持轻微的阴影变化，但不包含Y轴移动效果 + +## 业务组件规范 + +### 1. 组件文件组织结构 + +#### 业务模块组件结构 +``` +views/ +├── module-name/ # 业务模块 +│ ├── stores/ # 模块状态管理 +│ │ └── useModuleStore.js +│ ├── components/ # 模块内组件 +│ │ ├── ComponentA.vue +│ │ └── ComponentB.vue +│ ├── composables/ # 业务逻辑函数 +│ │ ├── useModuleData.js +│ │ └── useModuleOperations.js +│ ├── utils/ # 模块工具函数 +│ │ └── moduleUtils.js +│ ├── api/ # 模块API +│ │ └── moduleApi.js +│ ├── Dashboard.vue # 模块首页 +│ └── index.vue # 模块入口 +``` + +### 2. Composable 设计模式 + +#### 推荐使用 Composable 分离业务逻辑 +```javascript +// composables/useTableOperations.js +export function useTableOperations() { + const loading = ref(false) + const tableData = ref([]) + + const loadData = async () => { + loading.value = true + try { + // 数据加载逻辑 + } finally { + loading.value = false + } + } + + return { + loading, + tableData, + loadData + } +} +``` + +## 图标使用规范 + +### 必须使用 Element Plus 图标库 + +**基础操作图标** +```javascript +import { + // 基础操作 + Plus, // 新增 + Edit, // 编辑 + Delete, // 删除 + Search, // 搜索 + Refresh, // 刷新 + View, // 查看 + Setting, // 设置 + + // 文件操作 + Download, // 下载 + Upload, // 上传 + Document, // 文档 + Folder, // 文件夹 + FolderOpened, // 打开的文件夹 + + // 导航和布局 + Home, // 首页 + ArrowLeft, // 左箭头 + ArrowRight, // 右箭头 + ArrowUp, // 上箭头 + ArrowDown, // 下箭头 + + // 状态指示 + Check, // 成功/确认 + Close, // 关闭/失败 + Warning, // 警告 + Info, // 信息 + Success, // 成功 + Error, // 错误 + + // 用户和权限 + User, // 用户 + UserFilled, // 用户（填充） + Lock, // 锁定 + Unlock, // 解锁 + + // 通信和分享 + Message, // 消息 + Phone, // 电话 + Email, // 邮件 + Share, // 分享 + Link, // 链接 + + // 媒体类型 + Picture, // 图片 + Video, // 视频 + Audio, // 音频 + + // 业务功能 + Management, // 管理 + DataBoard, // 数据看板 + Grid, // 网格 + List, // 列表 + Calendar, // 日历 + Clock, // 时钟 + Location, // 位置 + + // 交互反馈 + Star, // 星标 + StarFilled, // 星标（填充） + Heart, // 喜欢 + HeartFilled, // 喜欢（填充） + + // 圆形图标变体 + CircleCheck, // 圆形确认 + CircleClose, // 圆形关闭 + CirclePlus, // 圆形加号 + + // 更多操作 + More, // 更多 + MoreFilled, // 更多（填充） + + // 展开收起 + Expand, // 展开 + Fold, // 收起 + + // 其他常用 + Filter, // 筛选 + Sort, // 排序 + Export, // 导出 + Import, // 导入 + Copy, // 复制 + Files, // 文件集合 + Histogram, // 柱状图 + PieChart, // 饼图 + TrendCharts // 趋势图 +} from '@element-plus/icons-vue' +``` + +### 图标使用原则 + +1. **统一性**：同一功能在不同页面必须使用相同图标 +2. **语义性**：图标含义要与功能匹配 +3. **一致性**：图标大小和颜色保持项目统一风格 + +### 常用图标映射 + +| 功能 | 图标 | 使用场景 | +|------|------|----------| +| 新增 | Plus | 新建数据、添加项目 | +| 编辑 | Edit | 修改数据、编辑内容 | +| 删除 | Delete | 删除数据、移除项目 | +| 搜索 | Search | 搜索框、查询功能 | +| 刷新 | Refresh | 重新加载数据 | +| 下载 | Download | 文件下载、数据导出 | +| 上传 | Upload | 文件上传、导入数据 | +| 查看 | View | 查看详情、预览 | +| 设置 | Setting | 配置、参数设置 | +| 首页 | Home | 返回首页、主页导航 | + +## 样式规范 + +### 1. 样式架构 + +项目采用分层样式架构： +- `src/assets/styles/index.scss` - 设计令牌和全局变量 +- `src/assets/styles/common.scss` - 公共页面样式 + +### 2. 间距规范 + +#### 统一Padding标准 +为确保界面的一致性和视觉平衡，项目采用统一的padding规范： + +**默认padding值：16px** + +```scss +// 标准间距规范 +.default-padding { + padding: 16px; // 默认内边距16px +} + +// 卡片组件标准间距 +.dashboard-card { + :deep(.el-card__body) { + padding: 16px !important; // 卡片内容区域16px + } + + .card-header { + padding: 16px 16px 12px; // 卡片头部：水平16px，底部12px + } +} + +// 统计卡片间距 +.stat-card { + padding: 16px; // 统计卡片16px +} +``` + +#### 特殊情况说明 +以下情况可根据设计需求调整： + +| 场景 | Padding值 | 说明 | +|------|-----------|------| +| **密集信息展示** | `12px` | 需要显示更多内容时 | +| **强调内容区域** | `20px` | 需要突出显示的重要内容 | +| **移动端适配** | `12px` | 小屏幕下的紧凑布局 | +| **表单输入区域** | `16px` | 保持与默认值一致 | +| **列表项内容** | `12px - 16px` | 根据列表密度调整 | + +#### 间距层级系统 +```scss +// 间距变量定义 +:root { + --padding-xs: 8px; // 极小间距 + --padding-sm: 12px; // 小间距 + --padding-md: 16px; // 默认间距（推荐） + --padding-lg: 20px; // 大间距 + --padding-xl: 24px; // 超大间距 +} + +// 使用示例 +.content-area { + padding: var(--padding-md); // 使用默认16px +} + +.compact-list { + padding: var(--padding-sm); // 使用紧凑12px +} +``` + +### 3. 全局样式规范 + +#### 使用 common.scss 统一样式 +项目已在 `src/assets/styles/common.scss` 中定义了页面头部样式，所有页面应使用统一的样式类： + +- `.page-header` - 页面头部容器 +- `.header-content` - 头部内容区域 +- `.header-left` - 头部左侧区域 +- `.page-title` - 页面标题 +- `.page-description` - 页面描述 +- `.header-actions` - 头部操作区域 +- `.add-btn` - 特殊的新增按钮样式 + +#### CSS 变量和设计令牌 +项目已在 `src/assets/styles/index.scss` 中定义了完整的设计令牌系统： + +- **颜色系统**: `--primary-color`, `--success-color` 等 +- **间距系统**: `--spacing-small`, `--spacing-medium` 等 +- **高度系统**: `--full-content-height`, `--card-content-height` 等 +- **阴影系统**: `--shadow-light`, `--shadow-medium` 等 +- **Z-Index层级**: `--z-index-header`, `--z-index-modal` 等 + +### 3. 边框颜色规范 + +#### 统一边框颜色使用 +为确保界面的一致性和品牌统一性，项目采用统一的边框颜色规范： + +**标准边框颜色：`var(--customer-board-color)`** + +```scss +// 标准边框样式 +.standard-border { + border: 1px solid var(--customer-board-color); +} + +// 卡片边框 +.card-container { + border: 1px solid var(--customer-board-color); + border-radius: 8px; +} + +// 分割线边框 +.divider-line { + border-bottom: 1px solid var(--customer-board-color); +} + +// 输入框边框 +.input-field { + border: 1px solid var(--customer-board-color); + border-radius: 4px; +} +``` + +#### 边框使用场景 +| 场景 | 边框样式 | 说明 | +|------|----------|------| +| **容器边框** | `1px solid var(--customer-board-color)` | 卡片、面板、弹窗等容器 | +| **分割线** | `1px solid var(--customer-board-color)` | 列表项、内容区域之间的分割 | +| **输入框** | `1px solid var(--customer-board-color)` | 表单输入框、选择器等 | +| **表格边框** | `1px solid var(--customer-board-color)` | 表格单元格、表头等 | +| **悬浮状态** | `1px solid var(--customer-board-color)` | 按钮、链接等悬浮时的边框 | + +#### 禁止使用的边框颜色 +- ❌ 硬编码的颜色值：`#e4e7ed`, `#f1f5f9`, `#e5e7eb` 等 +- ❌ 直接使用 Element Plus 默认边框色 +- ❌ 使用不统一的颜色变量 + +#### 正确示例 +```scss +// ✅ 正确：使用统一的边框颜色变量 +.email-list { + border-bottom: 1px solid var(--customer-board-color); +} + +// ✅ 正确：使用统一的边框颜色变量 +.sidebar-section { + border-bottom: 1px solid var(--customer-board-color); +} + +// ✅ 正确：使用统一的边框颜色变量 +.dialog-content { + border: 1px solid var(--customer-board-color); +} +``` + +#### 错误示例 +```scss +// ❌ 错误：使用硬编码颜色值 +.email-list { + border-bottom: 1px solid #e4e7ed; +} + +// ❌ 错误：使用不统一的颜色变量 +.sidebar-section { + border-bottom: 1px solid #f1f5f9; +} +``` + +### 4. 组件样式规范 + +#### Element Plus 组件样式增强 +项目已对 Element Plus 组件进行了样式增强： + +- **卡片组件**: 统一圆角和阴影 +- **抽屉组件**: 标准化头部和底部样式 +- **对话框组件**: 统一边框和间距 +- **滚动条**: 自定义滚动条样式 + +#### 页面布局类 +- `.main-card` - 主要内容卡片 +- `.search-section` - 搜索区域 +- `.table-section` - 表格区域 +- `.stats-section` - 统计区域 +- `.feature-section` - 功能区域 + +## 文件预览规范 + +### 使用 FileViewer 组件 + +**统一使用 FileViewer 组件处理文件预览** + +```vue + + + +``` + +### 支持的文件类型 + +- **Office文档**: DOC, DOCX, XLS, XLSX, PPT, PPTX +- **PDF文档**: PDF +- **图片文件**: JPG, PNG, GIF, BMP, SVG +- **文本文件**: TXT, MD, JSON, XML +- **视频文件**: MP4, AVI, MOV +- **音频文件**: MP3, WAV, OGG +- **在线文档**: 富文本内容 + +### FileViewer 组件特性 + +- 自动识别文件类型 +- 支持在线预览 +- 统一的预览界面 +- 不支持预览的文件显示下载提示 + +## 路由规范 + +### 1. 路由配置规范 + +#### 路由命名规范 +```javascript +// 路由命名遵循以下规则： +// 1. 使用 kebab-case 格式 +// 2. 层级结构清晰 +// 3. 名称具有语义性 + +const routes = [ + { + path: '/crm', + name: 'Crm', + component: Layout, + meta: { + title: 'CRM', + icon: 'UserFilled', + permission: 'crm' + }, + children: [ + { + path: 'customer', + name: 'CrmCustomer', + component: () => import('@/views/crm/CustomerInfo.vue'), + meta: { + title: '客户信息', + icon: 'User', + permission: 'crm:customer', + cache: true + } + } + ] + } +] +``` + +#### 路由 Meta 信息规范 +```javascript +// Meta 字段标准定义 +meta: { + title: '页面标题', // 必填：页面标题 + icon: 'ElementIcon', // 可选：菜单图标 + permission: 'module:action', // 可选：权限标识 + cache: true, // 可选：是否缓存页面 + hidden: false, // 可选：是否隐藏菜单 +``` + +### 2. 路由守卫规范 + +#### 权限检查流程 +```javascript +// 统一的路由守卫逻辑 +router.beforeEach(async (to, from, next) => { + const userStore = useUserStore() + const permissionStore = usePermissionStore() + + // 1. 公开页面直接放行 + if (PUBLIC_PAGES.has(to.path)) { + next() + return + } + + // 2. 登录状态检查 + if (!userStore.isLoggedIn) { + userStore.redirectToLoginWithUrl(to.fullPath, router) + return + } + + // 3. 权限检查 + if (to.meta.permission && !permissionStore.hasPermission(to.meta.permission)) { + next('/403') + return + } + + next() +}) +``` + +### 3. 路由跳转规范 + +#### 编程式导航 +```javascript +// 推荐：使用命名路由 +router.push({ name: 'CrmCustomer', params: { id: '123' } }) + +// 推荐：带查询参数 +router.push({ + name: 'CrmCustomer', + query: { tab: 'projects', status: 'active' } +}) + +// 避免：硬编码路径 +// router.push('/crm/customer/123') +``` + +#### 路由参数处理 +```javascript +// 在组件中获取路由参数 +const route = useRoute() +const router = useRouter() + +// 获取路径参数 +const customerId = route.params.id + +// 获取查询参数 +const activeTab = route.query.tab || 'basic' + +// 监听路由变化 +watch(() => route.params.id, (newId) => { + if (newId) { + loadCustomerData(newId) + } +}) +``` + +## 状态管理规范 + +### 1. Store 组织结构 + +#### Store 命名和文件组织 +``` +# 全局状态管理 +stores/ +├── user.js # 用户状态 +├── permission.js # 权限状态 +├── app.js # 应用全局状态 +└── utils/ # 状态工具 + └── storeHelpers.js + +# 业务模块状态管理（放在各自模块内） +views/ +├── crm/ +│ ├── stores/ +│ │ └── useCrmStore.js # CRM模块状态 +│ ├── components/ +│ └── ... +├── knowledge/ +│ ├── stores/ +│ │ └── useKnowledgeStore.js # 知识库模块状态 +│ ├── components/ +│ └── ... +└── email/ + ├── stores/ + │ └── useEmailStore.js # 邮件模块状态 + ├── components/ + └── ... +``` + +### 2. Store 设计规范 + +#### 标准 Store 结构 +```javascript +// views/crm/stores/useCrmStore.js +import { defineStore } from 'pinia' +import { ref, computed } from 'vue' +import * as crmApi from '../api/crmApi' + +export const useCrmStore = defineStore('crm', () => { + // ========== 状态定义 ========== + const customers = ref([]) + const projects = ref([]) + const loading = ref(false) + const error = ref(null) + + // ========== 计算属性 ========== + const activeCustomers = computed(() => + customers.value.filter(customer => customer.status === 'active') + ) + + const totalProjects = computed(() => projects.value.length) + + // ========== Actions ========== + const loadCustomers = async (params = {}) => { + loading.value = true + error.value = null + + try { + const response = await crmApi.getCustomerPage(params) + customers.value = response.records || [] + return response + } catch (err) { + error.value = err.message + throw err + } finally { + loading.value = false + } + } + + const addCustomer = async (customerData) => { + try { + const newCustomer = await crmApi.createCustomer(customerData) + customers.value.unshift(newCustomer) + return newCustomer + } catch (err) { + error.value = err.message + throw err + } + } + + const updateCustomer = async (id, customerData) => { + try { + const updatedCustomer = await crmApi.updateCustomer(id, customerData) + const index = customers.value.findIndex(c => c.id === id) + if (index !== -1) { + customers.value[index] = updatedCustomer + } + return updatedCustomer + } catch (err) { + error.value = err.message + throw err + } + } + + const removeCustomer = async (id) => { + try { + await crmApi.deleteCustomer(id) + customers.value = customers.value.filter(c => c.id !== id) + } catch (err) { + error.value = err.message + throw err + } + } + + // ========== 工具方法 ========== + const resetState = () => { + customers.value = [] + projects.value = [] + loading.value = false + error.value = null + } + + const findCustomerById = (id) => { + return customers.value.find(customer => customer.id === id) + } + + return { + // 状态 + customers, + projects, + loading, + error, + + // 计算属性 + activeCustomers, + totalProjects, + + // 方法 + loadCustomers, + addCustomer, + updateCustomer, + removeCustomer, + resetState, + findCustomerById + } +}) +``` + +### 3. Store 使用规范 + +#### 在组件中使用 Store +```javascript +// 组件中的标准用法 + +``` + +#### 跨 Store 通信 +```javascript +// 在业务模块 Store 中使用全局 Store +export const useCrmStore = defineStore('crm', () => { + const userStore = useUserStore() // 全局用户状态 + const permissionStore = usePermissionStore() // 全局权限状态 + + const loadCustomers = async () => { + // 检查权限 + if (!permissionStore.hasPermission('crm:customer:read')) { + throw new Error('没有访问权限') + } + + // 使用用户信息 + const params = { + userId: userStore.userId, + tenantId: userStore.currentTenant?.id + } + + // API调用... + } +}) +``` + +### 4. 状态持久化 + +#### 使用 localStorage 持久化 +```javascript +import { defineStore } from 'pinia' + +export const useAppStore = defineStore('app', () => { + // 从 localStorage 恢复状态 + const sidebarCollapsed = ref( + localStorage.getItem('sidebarCollapsed') === 'true' + ) + + const toggleSidebar = () => { + sidebarCollapsed.value = !sidebarCollapsed.value + // 持久化到 localStorage + localStorage.setItem('sidebarCollapsed', sidebarCollapsed.value.toString()) + } + + return { + sidebarCollapsed, + toggleSidebar + } +}) +``` + +## 接口处理规范 + +### 1. 接口调用规范 + +#### 基于 http.js 的统一调用 +项目已使用 `src/utils/http.js` 进行 Ajax 响应封装，所有接口调用必须使用统一的 request 方法： + +```javascript +// 正确：使用统一的 http 实例 +import request from '@/utils/http' + +export function getCustomerList(params) { + return request({ + url: '/smart-ops/crm/customer/page', + method: 'post', + data: params + }) +} + +// 错误：直接使用 axios +// import axios from 'axios' +// axios.post('/api/customer', data) +``` + +### 2. 接口文件组织规范 + +#### API 文件结构 +``` +# 全局API接口 +api/ +├── index.js # API 统一导出 +├── user.js # 用户相关接口 +├── permission.js # 权限相关接口 +└── wiki/ # Wiki相关接口 + ├── comment.js + ├── favorite.js + └── version.js + +# 业务模块API接口（放在各自模块内） +views/ +├── crm/ +│ └── api/ +│ └── crmApi.js # CRM模块接口 +├── email/ +│ └── api/ +│ └── emailApi.js # 邮件模块接口 +└── knowledge/ + └── api/ + └── knowledgeApi.js # 知识库模块接口 +``` + +#### 接口命名规范 +```javascript +// 命名规范：动词 + 资源名 + 操作类型 +// CRUD 操作标准命名 +export function getCustomerList(params) // 获取列表 +export function getCustomerPage(params) // 分页查询 +export function getCustomerDetail(id) // 获取详情 +export function createCustomer(data) // 创建 +export function updateCustomer(id, data) // 更新 +export function deleteCustomer(id) // 删除 + +// 特殊操作命名 +export function exportCustomers(params) // 导出 +export function importCustomers(file) // 导入 +export function batchDeleteCustomers(ids) // 批量删除 +export function enableCustomer(id) // 启用 +export function disableCustomer(id) // 禁用 +``` + +### 3. 接口文档规范 + +#### 标准接口注释 +```javascript +/** + * 获取客户分页列表 + * @param {Object} params - 查询参数 + * @param {number} params.pageNo - 页码（从1开始） + * @param {number} params.pageSize - 每页大小 + * @param {string} [params.keyword] - 搜索关键词 + * @param {string} [params.status] - 客户状态：active|inactive + * @param {string} [params.createTimeStart] - 创建时间开始 + * @param {string} [params.createTimeEnd] - 创建时间结束 + * @returns {Promise} 返回分页数据 + * @returns {Object[]} returns.records - 客户列表 + * @returns {number} returns.total - 总数量 + * @returns {number} returns.pageNo - 当前页码 + * @returns {number} returns.pageSize - 每页大小 + * + * @example + * const result = await getCustomerPage({ + * pageNo: 1, + * pageSize: 20, + * keyword: '客户名称', + * status: 'active' + * }) + */ +export function getCustomerPage(params) { + return request({ + url: '/smart-ops/crm/customer/page', + method: 'post', + data: params + }) +} +``` + +### 4. Mock 数据规范 + +#### Mock 开关管理 +```javascript +// views/email/api/emailApi.js - Mock模式示例 +import http from '@/utils/http' +import { EMAIL_LIST, createMockResponse } from '@/mock/emailData' + +// Mock模式开关 +const USE_MOCK = process.env.NODE_ENV === 'development' + +export function getEmailList(params) { + if (USE_MOCK) { + // Mock 数据处理逻辑 + let filteredEmails = [...EMAIL_LIST] + + // 搜索筛选 + if (params.search) { + const query = params.search.toLowerCase() + filteredEmails = filteredEmails.filter(email => + email.subject?.toLowerCase().includes(query) + ) + } + + return Promise.resolve(createMockResponse(filteredEmails)) + } + + // 真实接口调用 + return http({ + url: '/smart-ops/email/list', + method: 'post', + data: params + }) +} +``` + +### 5. 错误处理规范 + +#### 统一错误处理模式 +```javascript +// 在 composable 中处理接口错误 +export function useCustomerOperations() { + const loading = ref(false) + const error = ref(null) + + const loadCustomers = async (params) => { + loading.value = true + error.value = null + + try { + const result = await getCustomerPage(params) + return result + } catch (err) { + error.value = err.message || '获取客户列表失败' + ElMessage.error(error.value) + throw err + } finally { + loading.value = false + } + } + + return { + loading, + error, + loadCustomers + } +} +``` + +#### 标准错误处理 +```javascript +// 统一的错误处理模式 +export function createCustomer(data) { + return request({ + url: '/smart-ops/crm/customer/create', + method: 'post', + data + }) +} + +// 在 composable 中处理错误 +export function useCustomerOperations() { + const createCustomer = async (data) => { + try { + const result = await createCustomerApi(data) + ElMessage.success('创建客户成功') + return result + } catch (error) { + ElMessage.error(error.message || '创建客户失败') + throw error + } + } + + return { createCustomer } +} +``` + +### 6. 文件上传/下载规范 + +#### 文件上传规范 +**必须使用已封装的阿里云OSS上传组件** + +```javascript +// 使用项目封装的OSS上传工具 +import { uesOssUpload } from '@/utils/uesOssUpload' + +// 在组件中使用OSS上传 +export function useFileUpload() { + const uploadRequest = uesOssUpload() + + const handleUpload = async (file, options = {}) => { + try { + const result = await uploadRequest.upload(file, { + onProgress: (progress) => { + console.log(`上传进度: ${progress}%`) + }, + ...options + }) + + return { + fileId: result.fileId, + fileName: result.fileName, + originalName: file.name, + fileSize: file.size, + fileType: file.type, + filePath: result.filePath + } + } catch (error) { + ElMessage.error('文件上传失败') + throw error + } + } + + return { handleUpload } +} +``` + +#### 文件下载规范 +**使用 FileUtils 工具类统一处理文件下载** + +```javascript +// utils/fileUtils.js - 添加标准下载方法 +import SystemConfig from '@/config/config' +import { ElMessage } from 'element-plus' + +class FileUtils { + /** + * 下载文件 + * @param {string} fileId - 文件ID + * @param {string} fileName - 文件名 + * @returns {Promise} + */ + static async downloadFile(fileId, fileName) { + if (!fileId) { + ElMessage.error('文件ID不能为空') + return + } + + if (!fileName) { + ElMessage.error('文件名不能为空') + return + } + + const downloadUrl = SystemConfig.FILE_DOWNLOAD_BASE_URL + `/${fileId}?fileName=${encodeURIComponent(fileName)}` + + try { + const response = await fetch(downloadUrl) + if (!response.ok) { + throw new Error(`HTTP error! status: ${response.status}`) + } + + const blob = await response.blob() + const url = window.URL.createObjectURL(blob) + const link = document.createElement('a') + link.href = url + link.download = fileName + document.body.appendChild(link) + link.click() + document.body.removeChild(link) + window.URL.revokeObjectURL(url) + + ElMessage.success('开始下载文件') + } catch (error) { + console.error('下载文件失败:', error) + ElMessage.error('下载文件失败') + throw error + } + } + + /** + * 下载文件（兼容对象参数） + * @param {Object} file - 文件信息对象 + * @returns {Promise} + */ + static async downloadFileByObject(file) { + if (!file) { + ElMessage.error('文件信息为空') + return + } + + const fileId = file.fileId || file.id + const fileName = file.originalName || file.fileName || file.name || '文件' + + return this.downloadFile(fileId, fileName) + } +} + +export default FileUtils +``` + +#### 在组件中使用 +```javascript +// 在业务组件中使用 +import FileUtils from '@/utils/fileUtils' + +// 方式1：直接传入fileId和fileName +const handleDownload = async () => { + try { + await FileUtils.downloadFile(fileId, fileName) + } catch (error) { + console.error('下载失败:', error) + } +} + +// 方式2：传入文件对象（兼容现有代码） +const handleDownloadByObject = async (file) => { + try { + await FileUtils.downloadFileByObject(file) + } catch (error) { + console.error('下载失败:', error) + } +} +``` + +## 最佳实践 + +### 1. 组件设计原则 + +#### 单一职责原则 +- 每个组件只负责一个功能领域 +- 使用 composable 函数分离业务逻辑 +- 避免组件代码超过 500 行 + +#### 可复用性原则 +- 提取公共逻辑到 composable 函数 +- 业务组件放在模块的 components 文件夹 +- 通用组件放在 src/components 文件夹 + +#### Composable 模式 +```javascript +// 推荐：使用 composable 管理复杂逻辑 +export function useFileOperations() { + const loading = ref(false) + + const uploadFile = async (file) => { + loading.value = true + try { + // 上传逻辑 + } finally { + loading.value = false + } + } + + return { + loading, + uploadFile + } +} +``` + +### 2. 代码质量规范 + +#### 组件文档注释 +```javascript +/** + * 文件预览组件 + * @description 支持多种文件类型的在线预览 + * @author 团队名称 + * @date 2024-01-01 + */ + +// Props 定义 +const props = defineProps({ + file: { + type: Object, + required: true, + default: () => ({}) + } +}) +``` + +#### 统一错误处理 +```javascript +// 在 composable 中处理错误 +export function useApiCall() { + const loading = ref(false) + const error = ref(null) + + const execute = async (apiFunction, errorMessage = '操作失败') => { + loading.value = true + error.value = null + + try { + const result = await apiFunction() + return result + } catch (err) { + error.value = err + ElMessage.error(errorMessage) + throw err + } finally { + loading.value = false + } + } + + return { loading, error, execute } +} +``` + +### 3. 性能优化建议 + +#### 组件懒加载 +```javascript +// 推荐：使用动态组件加载器 +import { useDynamicLoader } from '@/utils/dynamicComponentLoader' + +const { getAsyncComponent } = useDynamicLoader() +const LazyDialog = getAsyncComponent('CreateDialog') +``` + +#### 大数据优化 +```vue + + + + +``` + +## 总结 + +本设计规范确保了项目的统一性和可维护性，所有开发成员应严格遵循。 + +### 核心要求 +1. **页面结构统一**: 使用 PageContainer + 标准页面结构 +2. **组件库优先**: 基于 Element Plus，避免重度定制 +3. **表格统一**: 必须使用 vxe-table +4. **文件预览统一**: 使用 FileViewer 组件 +5. **图标规范**: 只使用 Element Plus 图标库 +6. **样式统一**: 使用 common.scss 中的全局样式 +7. **路由规范**: 统一路由配置和守卫机制 +8. **状态管理**: 业务模块内管理，全局状态分离 +9. **接口调用**: 基于 http.js 统一处理 +10. **业务组件**: 按模块组织，自包含结构 +11. **代码质量**: 单一职责、可复用、高性能 + +### 开发流程 +1. **新建页面**: 复制标准页面结构模板 +2. **配置路由**: 按照路由规范配置路由和权限 +3. **创建模块**: 在业务模块内创建 stores 和 api 目录 +4. **开发 Store**: 使用标准 Store 结构管理模块状态 +5. **开发 API**: 基于 http.js 创建模块接口调用 +6. **添加功能**: 优先使用现有组件和 composable +7. **样式开发**: 使用全局样式类，避免重复定义 +8. **图标选择**: 从规范的图标列表中选择 +9. **测试验证**: 确保功能正常和性能良好 +10. **代码审查**: 确保符合所有规范要求 + +--- + +*版本: v2.0* +*更新时间: 2024年1月* +*维护团队: 前端架构团队* \ No newline at end of file diff --git a/数据/#数据与表结构.md b/数据/#数据与表结构.md new file mode 100644 index 0000000..7891c15 --- /dev/null +++ b/数据/#数据与表结构.md @@ -0,0 +1,185 @@ +#数据与表结构 +## 一、数据概览 + +### 1.1 数据源 + +| 数据表 | Sheet | 记录数 | 时间范围 | 核心内容 | +|--------|-------|--------|----------|----------| +| 不良事件数据 | POWER BI 总信息 | 1,000 条 | 2023-12 ~ 2026-04 | 上报至监管的不良事件记录 | +| 入院量数据 | Sheet1 | 1,000 条 | 2024 ~ 2026（按月） | 各医院各产品的销售金额与数量 | +| 质量投诉数据 | complaint form | 1,000 条 | 2023-08 ~ 2026-04 | 客户质量投诉的全生命周期记录 | + +所有数据为模拟数据，并且假设均已清理、规整完毕。 + +### 1.2 各表字段清单 + +**不良事件表（13 字段）** + +| 字段 | 说明 | 典型值 | +|------|------|--------| +| 报告编码 | 不良事件唯一编号 | SIM-2024-000001 | +| 单位名称 | 报告医院 | 15 家三甲医院 | +| 事业线 | 产品所属事业线 | 外科产品、透析产品、输液治疗、诊断/监测耗材 | +| 产品名称 | 涉及产品 | 13 种产品 | +| 注册证编号 | 产品注册证号 | 国械注进/国械注准 | +| 注册人 | 注册持有人 | 贝朗医疗（苏州）有限公司 | +| 型号 | 产品型号 | 30 种型号 | +| 产品批号 | 生产批号 | — | +| 伤害 | 是否造成伤害 | 全部为"是" | +| 伤害表现 | 伤害的临床表现 | 35 种表现（感染、出血、疼痛、静脉炎等） | +| 器械故障表现 | 器械故障描述 | 53 种故障表现 | +| 审核日期 | 事件审核日期 | — | + +**入院量数据（24 字段）** + +| 字段 | 说明 | 典型值 | +|------|------|--------| +| Year / Month | 销售年月 | 2024–2026 | +| HospitalName / HospitalCode | 医院名称及代码 | 10 家医院 | +| DealerName / DealerCode | 经销商名称及代码 | 8 家经销商 | +| Province / City | 省市 | 10 省市 | +| GlobalDivision | 全球事业部 | Avitum、Hospital Care、Aesculap | +| LocalDivision | 本地事业部 | 透析、输液治疗、外科 | +| BU | 业务单元 | Renal Care BU、IV Therapy BU、Surgical BU | +| ProductLine | 产品线 | 透析耗材、静脉输注、缝线与外科耗材、营养输注 | +| ProductLineType | 产品线类型 | 透析器、留置针、可吸收缝线等 8 种 | +| Material / MaterialDesc | 物料号 / 物料描述 | 8 种物料 | +| CY Amt / LY Amt | 当年/去年销售金额 | — | +| Growth Amt / Growth% Amt | 金额增长及增长率 | — | +| CY Qty / LY Qty | 当年/去年销售数量 | — | +| Growth Qty / Growth% Qty | 数量增长及增长率 | — | +| CY LE AMT | 当年最新预测金额 | — | + +**质量投诉数据（31 字段）** + +| 字段 | 说明 | 典型值 | +|------|------|--------| +| C3编号 | 投诉唯一编号 | C3-2026-000001 | +| 型号 / 批号 / 序列号 | 产品标识 | — | +| 生产企业名称 | 生产企业 | 贝朗医疗（苏州/上海） | +| 注册证号 | 产品注册证 | 国械注进/国械注准 | +| 产品名称 | 投诉产品 | 5 种核心产品 | +| 医院名称 | 投诉医院 | 10 家医院 | +| 投诉联系人 / 联系人电话 | 医院端联系方式 | — | +| 故障类型 | 故障大类 | 渗漏、断裂、流速异常、包装破损、连接不牢、堵塞、标签不清 | +| 投诉详情（中文） | 故障详细描述 | 自由文本 | +| 上报人 | 公司内上报人 | 护理部、临床工程、设备科、质控办 | +| BU | 业务单元 | Renal Care BU、IV Therapy BU、Surgical BU | +| C3登记日期 / C3登记月 | 投诉登记时间 | — | +| 是否不良事件 | 是否升级为不良事件 | 是(252条) / 否(748条) | +| 不良事件（否） | 未升级原因 | 未造成患者伤害、使用前发现、仅质量缺陷 | +| 上报坏品数量 / 坏品退回QA / 退回原厂 | 样品退回链路数量 | — | +| 调查报告完成日期 | 调查完成时间 | — | +| 调查报告（处理意见） | 英文处理意见 | Need more info、No defect found、Training reinforced | +| 调查报告中文（处理意见） | 中文处理意见 | — | +| 调查结论（处理结果） | 调查结论 | 产品缺陷成立、未复现、操作不当、运输损伤、资料不足 | +| 赔付结论 | 赔付方式 | 换货、折让、退款、无赔付、其他协商处理 | +| 关闭日期 | 投诉关闭时间 | — | +| 投诉状态 | 当前状态 | 已关闭、调查中、新建、待补充 | +| 有样品返回 | 是否有样品退回 | 是/— | +| 事业部 | 中文事业部名称 | 透析、输液治疗、外科 | +| 例数 | 涉及患者例数 | — | + +--- + +## 二、数据关系梳理 + +### 2.1 三张表用途说明 +- 不良事件数据表来源于监管机构，最初报告者是医院，由医院向监管机构报告，监管机构再将报告创数给器械企业； +- 医院报告时间的原因有多种： + -确实为值得关注的不良事件，希望引起企业的重视； + -为了满足报告数量要求，满足监管部门的任务； + -与患者发生纠纷，将事件及时告知。 + +### 2.2 入院数量表 +- 本表数据为企业提供，数据准确； + +### 2.3 质量投诉数据 +- 数据真实性可以接受，不用担心虚假数据； +- 可能存在即为质量投诉，同时出现在不良事件报告中的数据。 + + +### 2.1 三表关联关系图 + + +#### 三表数据关联分析 + +1. **质量投诉数据 ↔ 入院量数据** + - 分析投诉率（某产品/医院的投诉数 ÷ 入院量），评估不同医院、产品或时间段下的投诉发生频率。 + - 关键关联字段：医院名称、产品名称（需模糊匹配）、BU/事业部。 + +2. **不良事件数据 ↔ 入院量数据** + - 用于计算不良事件发生率，观察事件报告的分布与产品/医院相关性。 + - 关键关联字段：医院名称、产品名称（需模糊匹配）、BU/事业部。 + +3. **质量投诉数据 ↔ 不良事件数据** + - 判断是否存在“同一投诉已升级为不良事件”的重合情形。重合部分有更高分析价值，可用于过程追溯和根因分析。 + - 关键字段：投诉唯一编号、是否不良事件、医院名称、产品名称、注册证号、型号、批号、时间等。 + +--- + +#### 结构与字段关系交互图 + +``` + (1) (3) +┌───────────────┐ 医院名称/产品名称 ┌───────────────┐ +│ │◄──────────────────────────────────│ │ +│ 入院量数据 │ │ 质量投诉数据 │ +│ (Sales Data) │──────────────────────────────────►│ (Complaint) │ +│ │ 医院名称/产品名称/BU/事业部 │ │ +└───────────────┘ └───────────────┘ + ▲ │ + │ │ + │ │ + │ (2) 是否不良事件/投诉编号/产品信息/时间 + │ │ +┌───────────────┐ 医院名称/产品/时间等 ┌──────┴────────┐ +│ │◄─────────────────────────────────│ │ +│ 不良事件数据 │ │ 质量投诉数据 │ +│ (AdverseEvent)│─────────────────────────────────►│ (Complaint) │ +│ │ 医院名称/产品/BU/事业部 │ │ +└───────────────┘ └───────────────┘ + ▲ + │ + │ + 医院名称/产品名称/BU/事业部 + │ +┌───────────────┐ +│ 入院量数据 │ +└───────────────┘ +``` + +### 2.2 关键关联字段详解 + +#### （一）强关联字段（可直接 Join） + +| 关联维度 | 表 A 字段 | 表 B 字段 | 匹配方式 | 重叠情况 | +|----------|-----------|-----------|----------|----------| +| **医院** | 入院量.HospitalName | 投诉.医院名称 | 精确匹配 | 10 家医院完全重叠 | +| **医院** | 入院量.HospitalName | 不良事件.单位名称 | 精确匹配 | 10 家重叠（不良事件多 5 家） | +| **医院** | 投诉.医院名称 | 不良事件.单位名称 | 精确匹配 | 10 家完全重叠 | +| **BU** | 入院量.BU | 投诉.BU | 精确匹配 | 3 个 BU 完全一致 | +| **事业部** | 入院量.LocalDivision | 投诉.事业部 | 精确匹配 | 透析、输液治疗、外科 | +| **型号** | 不良事件.型号 | 投诉.型号 | 精确匹配 | 7 个型号重叠 | + + +#### （二）投诉 → 不良事件的上下游关系 + +质量投诉数据中的 **"是否不良事件"** 字段是连接投诉表与不良事件表的核心业务逻辑： +- **"是"（252 条，25.2%）**：该投诉已升级为不良事件，理论上在不良事件表中应有对应记录 +- **"否"（748 条，74.8%）**：未升级，原因记录在"不良事件（否）"字段 + +### 2.3 数据维度层级关系 + +``` +GlobalDivision (Avitum / Hospital Care / Aesculap) + └─ LocalDivision / 事业部 (透析 / 输液治疗 / 外科) + └─ BU (Renal Care BU / IV Therapy BU / Surgical BU) + └─ ProductLine (透析耗材 / 静脉输注 / 缝线与外科耗材 / 营养输注) + └─ ProductLineType (透析器 / 留置针 / 可吸收缝线 / ...) + └─ Material / 产品名称 (血液透析器 1.4m² / ...) + └─ 型号 (HD-180 / Introcan Safety 20G / ...) + └─ 批号 (单个生产批次) +``` + +--- diff --git a/数据/不良事件数据-模拟1000条-20260414.xlsx b/数据/不良事件数据-模拟1000条-20260414.xlsx new file mode 100644 index 0000000..b4156b9 Binary files /dev/null and b/数据/不良事件数据-模拟1000条-20260414.xlsx differ diff --git a/数据/入院量数据-模拟1000条-20260414.xlsx b/数据/入院量数据-模拟1000条-20260414.xlsx new file mode 100644 index 0000000..9855a47 Binary files /dev/null and b/数据/入院量数据-模拟1000条-20260414.xlsx differ diff --git a/数据/质量投诉数据-模拟1000条-20260414.xlsx b/数据/质量投诉数据-模拟1000条-20260414.xlsx new file mode 100644 index 0000000..f7ca804 Binary files /dev/null and b/数据/质量投诉数据-模拟1000条-20260414.xlsx differ diff --git a/数据准备过程/模拟数据生成-提示词/generate_simulated_admission.py b/数据准备过程/模拟数据生成-提示词/generate_simulated_admission.py new file mode 100644 index 0000000..6b31dc2 --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/generate_simulated_admission.py @@ -0,0 +1,314 @@ +# -*- coding: utf-8 -*- +"""按“生成入院量模拟数据.md”生成入院量模拟数据。""" + +from __future__ import annotations + +import random +from dataclasses import dataclass +from datetime import date +from pathlib import Path + +from openpyxl import Workbook +from openpyxl.utils import get_column_letter + +ROOT = Path(__file__).resolve().parent + +HEADERS = [ + "Year", + "Month", + "HospitalName", + "HospitalCode", + "DealerName", + "DealerCode", + "Province", + "City", + "GlobalDivision", + "LocalDivision", + "BU", + "ProductLine", + "ProductLineType", + "Material", + "MaterialDesc", + "CY Amt", + "LY Amt", + "Growth Amt", + "Growth% Amt", + "CY Qty", + "LY Qty", + "Growth Qty", + "Growth% Qty", + "CY LE AMT", +] + + +@dataclass(frozen=True) +class Hospital: + name: str + code: str + province: str + city: str + + +@dataclass(frozen=True) +class Dealer: + name: str + code: str + + +@dataclass(frozen=True) +class MaterialProfile: + global_div: str + local_div: str + bu: str + product_line: str + product_line_type: str + material: str + material_desc: str + unit_price_low: float + unit_price_high: float + weight: int + + +HOSPITALS = [ + Hospital("上海市第一人民医院", "H310001", "上海市", "上海市"), + Hospital("浙江大学医学院附属第二医院", "H330001", "浙江省", "杭州市"), + Hospital("四川大学华西医院", "H510001", "四川省", "成都市"), + Hospital("广东省人民医院", "H440001", "广东省", "广州市"), + Hospital("中南大学湘雅医院", "H430001", "湖南省", "长沙市"), + Hospital("山东大学齐鲁医院", "H370001", "山东省", "济南市"), + Hospital("西安交通大学第一附属医院", "H610001", "陕西省", "西安市"), + Hospital("南京鼓楼医院", "H320001", "江苏省", "南京市"), + Hospital("福建省立医院", "H350001", "福建省", "福州市"), + Hospital("郑州大学第一附属医院", "H410001", "河南省", "郑州市"), +] + +DEALERS = [ + Dealer("上海睿康医疗器械有限公司", "D10001"), + Dealer("浙江和信医药科技有限公司", "D10002"), + Dealer("广州安泰医疗供应链有限公司", "D10003"), + Dealer("成都优诺医疗器械有限公司", "D10004"), + Dealer("南京博瑞医疗科技有限公司", "D10005"), + Dealer("济南康惠医疗设备有限公司", "D10006"), + Dealer("西安同泽医药贸易有限公司", "D10007"), + Dealer("福州海润医疗器械有限公司", "D10008"), +] + +MATERIALS = [ + MaterialProfile( + "Hospital Care", + "输液治疗", + "IV Therapy BU", + "静脉输注", + "留置针", + "MAT203145", + "一次性使用静脉留置针 20G", + 36, + 58, + 160, + ), + MaterialProfile( + "Hospital Care", + "输液治疗", + "IV Therapy BU", + "静脉输注", + "输液器", + "MAT203148", + "一次性使用精密过滤输液器", + 22, + 40, + 150, + ), + MaterialProfile( + "Hospital Care", + "输液治疗", + "IV Therapy BU", + "静脉输注", + "注射器", + "MAT203166", + "一次性使用无菌注射器 20ml", + 4.5, + 8.5, + 110, + ), + MaterialProfile( + "Avitum", + "透析", + "Renal Care BU", + "透析耗材", + "透析器", + "MAT301201", + "血液透析器 1.4m²", + 145, + 230, + 130, + ), + MaterialProfile( + "Avitum", + "透析", + "Renal Care BU", + "透析耗材", + "透析管路", + "MAT301216", + "血液透析管路 AV-SET", + 85, + 130, + 90, + ), + MaterialProfile( + "Aesculap", + "外科", + "Surgical BU", + "缝线与外科耗材", + "可吸收缝线", + "MAT402018", + "可吸收性外科缝线 3-0", + 120, + 180, + 95, + ), + MaterialProfile( + "Aesculap", + "外科", + "Surgical BU", + "缝线与外科耗材", + "非吸收缝线", + "MAT402026", + "非吸收性外科缝线 4-0", + 88, + 150, + 85, + ), + MaterialProfile( + "Hospital Care", + "输液治疗", + "IV Therapy BU", + "营养输注", + "肠内营养器械", + "MAT203199", + "一次性使用肠内营养输液器", + 26, + 44, + 70, + ), +] + + +def weighted_materials() -> list[MaterialProfile]: + out: list[MaterialProfile] = [] + for m in MATERIALS: + out.extend([m] * m.weight) + return out + + +def quarter_factor(month: int) -> float: + if month in (10, 11, 12): + return 1.08 + if month in (7, 8, 9): + return 1.03 + return 1.0 + + +def generate_rows(n: int, seed: int) -> list[list]: + rng = random.Random(seed) + mat_pool = weighted_materials() + years = [2024, 2025, 2026] + rows: list[list] = [] + + for _ in range(n): + year = rng.choice(years) + month = rng.randint(1, 12) + hospital = rng.choice(HOSPITALS) + dealer = rng.choice(DEALERS) + mat = rng.choice(mat_pool) + + # 数量：近似反映季度小幅波动 + base_cy_qty = rng.randint(120, 2200) + cy_qty = int(round(base_cy_qty * quarter_factor(month))) + + ly_is_zero = rng.random() < 0.05 + if ly_is_zero: + ly_qty = 0 + else: + change_ratio_qty = rng.uniform(-0.28, 0.38) + ly_qty = max(1, int(round(cy_qty / (1 + change_ratio_qty)))) + + growth_qty = cy_qty - ly_qty + growth_pct_qty = 0 if ly_qty == 0 else round(growth_qty / ly_qty, 4) + + # 金额：与数量和物料单价相关，保证可解释性 + unit_price_cy = rng.uniform(mat.unit_price_low, mat.unit_price_high) + cy_amt = round(cy_qty * unit_price_cy, 2) + + if ly_qty == 0: + ly_amt = 0.0 + else: + # 同一物料年度单价一般平稳波动 + unit_price_ly = unit_price_cy * rng.uniform(0.92, 1.08) + ly_amt = round(ly_qty * unit_price_ly, 2) + + growth_amt = round(cy_amt - ly_amt, 2) + growth_pct_amt = 0 if ly_amt == 0 else round(growth_amt / ly_amt, 4) + cy_le_amt = round(cy_amt * rng.uniform(0.90, 1.15), 2) + + rows.append( + [ + year, + month, + hospital.name, + hospital.code, + dealer.name, + dealer.code, + hospital.province, + hospital.city, + mat.global_div, + mat.local_div, + mat.bu, + mat.product_line, + mat.product_line_type, + mat.material, + mat.material_desc, + cy_amt, + ly_amt, + growth_amt, + growth_pct_amt, + cy_qty, + ly_qty, + growth_qty, + growth_pct_qty, + cy_le_amt, + ] + ) + return rows + + +def main() -> None: + today = date.today() + out_name = f"入院量数据-模拟1000条-{today:%Y%m%d}.xlsx" + out_path = ROOT / out_name + rows = generate_rows(1000, int(today.strftime("%Y%m%d"))) + + wb = Workbook() + ws = wb.active + ws.title = "Sheet1" + ws.append(HEADERS) + for row in rows: + ws.append(row) + + # 格式设置：金额/增长率显示友好 + amt_cols = ["P", "Q", "R", "X"] + pct_cols = ["S", "W"] + for r in range(2, 1002): + for col in amt_cols: + ws[f"{col}{r}"].number_format = "#,##0.00" + for col in pct_cols: + ws[f"{col}{r}"].number_format = "0.00%" + + for idx, _ in enumerate(HEADERS, start=1): + ws.column_dimensions[get_column_letter(idx)].width = 16 + + wb.save(out_path) + print(f"Written: {out_path}") + + +if __name__ == "__main__": + main() diff --git a/数据准备过程/模拟数据生成-提示词/generate_simulated_ae.py b/数据准备过程/模拟数据生成-提示词/generate_simulated_ae.py new file mode 100644 index 0000000..69ec8d5 --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/generate_simulated_ae.py @@ -0,0 +1,320 @@ +# -*- coding: utf-8 -*- +"""生成贝朗相关产品模拟不良事件数据（合成数据，仅供分析/培训）。 + +依据：贝朗数据/生成不良事件模拟数据.md +""" +from __future__ import annotations + +import random +from datetime import date, timedelta +from pathlib import Path + +from openpyxl import Workbook +from openpyxl.utils import get_column_letter + +ROOT = Path(__file__).resolve().parent + +HEADERS = [ + "报告编码", + "CC", + "单位名称", + "事业线", + "产品名称", + "注册证编号/曾用注册证编号", + "注册人", + "型号", + "产品批号", + "伤害", + "伤害表现", + "器械故障表现", + "审核日期", +] + +# 产品名：基于贝朗中国常见产品线及行业通用命名归纳；具体注册信息以 NMPA 为准（本表为模拟） +# events: (伤害表现K, 器械故障表现L)；J 列固定为「是」（见提示词） +PRODUCT_PROFILES: list[dict] = [ + { + "line": "输液治疗", + "name": "一次性使用静脉留置针", + "weight": 180, + "models": ("4251624", "4251625", "Introcan Safety 20G", "Introcan 18G"), + "events": [ + ("穿刺部位疼痛", "套管与导管座连接处渗漏"), + ("血肿", "回血观察窗模糊影响血流判断"), + ("出血", "针尖保护装置回弹不畅"), + ("红斑", "肝素帽旋紧后微量渗液"), + ("瘙痒", "延长管打折致滴速下降"), + ("水肿", "留置针固定翼粘贴失效"), + ("静脉炎", "导管腔内回血阻力增高"), + ("局部感染征象", "三通接头裂纹"), + ], + }, + { + "line": "输液治疗", + "name": "一次性使用输液器", + "weight": 160, + "models": ("IS-7.0", "IS-5.0", "4053000"), + "events": [ + ("输液部位疼痛", "滴斗液面波动异常"), + ("空气栓塞相关症状（已处理）", "管路接头松动致滴管内进气"), + ("心悸", "流量调节轮锁止不良"), + ("瘙痒", "精密过滤器外壳裂纹"), + ("渗漏致皮肤红斑", "穿刺器与药瓶胶塞密封不严"), + ("恶心", "滴速过快相关不适"), + ("寒战", "输液管路可见异物附着"), + ], + }, + { + "line": "输液治疗", + "name": "一次性使用精密过滤输液器", + "weight": 90, + "models": ("PF-5.0", "PF-7.0"), + "events": [ + ("低血压", "过滤膜侧压力升高致滴速骤降"), + ("头痛", "排气孔堵塞需二次排气"), + ("胸闷", "侧孔进气不畅"), + ("发热", "过滤器下游管路温度异常升高"), + ], + }, + { + "line": "输液治疗", + "name": "一次性使用输注延长管", + "weight": 70, + "models": ("EX-50cm", "EX-100cm"), + "events": [ + ("输注中断相关焦虑", "螺旋接口与泵管不匹配"), + ("药物输注延迟", "延长管扭转触发流量报警"), + ("局部肿胀", "接口渗液"), + ], + }, + { + "line": "输液治疗", + "name": "一次性使用肠内营养输液器", + "weight": 50, + "models": ("EN-SET-1.2", "EN-SET-2.0"), + "events": [ + ("腹胀", "营养袋接口与泵管连接处渗漏"), + ("呕吐", "滴速传感器识别不稳定"), + ("腹泻", "营养液温度偏低相关不适"), + ], + }, + { + "line": "透析产品", + "name": "血液透析器", + "weight": 120, + "models": ("Diacap Pro 1.3", "Diacap 1.4", "HD-180"), + "events": [ + ("透析中低血压", "跨膜压波动偏大"), + ("出血", "动脉端管路接头渗液"), + ("头痛", "透析液侧压力传感器报警"), + ("肌肉痉挛", "透析器外壳细微裂纹"), + ("恶心", "超滤率设置与监测不一致"), + ("胸痛", "静脉压升高报警"), + ], + }, + { + "line": "透析产品", + "name": "血液透析浓缩液", + "weight": 60, + "models": ("BIC-35", "ACID-8L"), + "events": [ + ("恶心", "浓缩液桶盖密封条变形渗漏"), + ("呕吐", "电导度监测短暂漂移"), + ("低血压", "透析液成分配比异常相关不适"), + ], + }, + { + "line": "透析产品", + "name": "血液透析管路", + "weight": 55, + "models": ("AV-SET-A", "AV-SET-P"), + "events": [ + ("失血相关血红蛋白下降", "动脉壶液面持续下降"), + ("出血", "泵管段磨损起皱"), + ("寒战", "管路预冲残留气泡"), + ], + }, + { + "line": "外科产品", + "name": "可吸收性外科缝线", + "weight": 75, + "models": ("Novosyn 3-0", "Monosyn 4-0"), + "events": [ + ("切口裂开", "缝线结滑脱"), + ("疼痛", "缝针弯曲"), + ("出血", "线体断裂残留"), + ("感染征象", "缝线张力过早丧失"), + ], + }, + { + "line": "外科产品", + "name": "非吸收性外科缝线", + "weight": 50, + "models": ("Premilene 3-0", "Dafilon 5-0"), + "events": [ + ("异物感", "线结切割组织"), + ("水肿", "缝针与线体连接处松动"), + ("红斑", "缝线表面粗糙刺激"), + ], + }, + { + "line": "外科产品", + "name": "一次性使用无菌手术膜", + "weight": 35, + "models": ("OP-FILM-45", "OP-FILM-60"), + "events": [ + ("皮肤红斑", "粘性不足边缘翘起"), + ("疼痛", "去除敷料时皮肤撕脱"), + ("瘙痒", "敷料下汗液积聚刺激"), + ], + }, + { + "line": "诊断/监测耗材", + "name": "一次性使用动脉采血器", + "weight": 30, + "models": ("ABG-3ml", "SAFE-ABG"), + "events": [ + ("血肿", "针头保护套脱落困难"), + ("出血", "肝素化不足标本凝固需重新采血"), + ("疼痛", "采血后桡动脉痉挛"), + ], + }, + { + "line": "输液治疗", + "name": "一次性使用无菌注射器", + "weight": 25, + "models": ("10ml Luer", "20ml Luer"), + "events": [ + ("疼痛", "推杆卡顿致推注阻力骤增"), + ("给药剂量偏差相关不适", "刻度印刷模糊"), + ("局部肿胀", "针头与针座连接处渗漏"), + ], + }, +] + +REGISTRANTS = ( + "贝朗医疗（上海）国际贸易有限公司", + "贝朗爱敦（上海）医疗管理有限公司", + "贝朗医疗（苏州）有限公司", +) + +HOSPITALS = ( + "上海市第一人民医院", + "浙江大学医学院附属第二医院", + "四川大学华西医院", + "广东省人民医院", + "华中科技大学同济医学院附属协和医院", + "中南大学湘雅医院", + "山东大学齐鲁医院", + "中国医科大学附属第一医院", + "西安交通大学第一附属医院", + "南京鼓楼医院", + "福建省立医院", + "重庆医科大学附属第一医院", + "天津市肿瘤医院", + "郑州大学第一附属医院", + "昆明医科大学第一附属医院", +) + +CC_POOL = ( + "质量反馈", + "临床使用", + "包装标识", + "灭菌外观", + "物流储运", + "培训咨询", + "不良事件", +) + + +def weighted_products() -> list[dict]: + pool: list[dict] = [] + for p in PRODUCT_PROFILES: + pool.extend([p] * p["weight"]) + return pool + + +def random_reg_number(rng: random.Random) -> str: + kinds = ("国械注进20", "国械注进201", "国械注准20", "国械注准201") + return f"{rng.choice(kinds)}{rng.randint(5, 9)}{rng.randint(100000, 999999)}" + + +def random_batch(rng: random.Random) -> str: + # 约 1% 概率重复上一批号（模拟同批聚集），其余唯一风格 + return f"{rng.choice('ABCDEFGHJK')}{rng.randint(100000, 999999)}{rng.choice('0123456789')}" + + +def random_workday(rng: random.Random, end: date) -> date: + start = end - timedelta(days=365 * 2 + 120) + d = start + timedelta(days=rng.randint(0, (end - start).days)) + while d.weekday() >= 5: + d -= timedelta(days=1) + return d + + +def build_rows(n: int, rng: random.Random, end_d: date) -> list[list]: + pool = weighted_products() + rows: list[list] = [] + prev_batch: str | None = None + + for i in range(1, n + 1): + prof = rng.choice(pool) + harm_k, device_fault = rng.choice(prof["events"]) + code = f"SIM-2024-{i:06d}" + + if prev_batch is not None and rng.random() < 0.01: + batch = prev_batch + else: + batch = random_batch(rng) + prev_batch = batch + + rows.append( + [ + code, + rng.choice(CC_POOL), + rng.choice(HOSPITALS), + prof["line"], + prof["name"], + random_reg_number(rng), + rng.choice(REGISTRANTS), + rng.choice(prof["models"]), + batch, + "是", + harm_k, + device_fault, + random_workday(rng, end_d), + ] + ) + return rows + + +def main() -> None: + end_d = date.today() + rng = random.Random(int(end_d.strftime("%Y%m%d"))) + out_name = f"不良事件数据-模拟1000条-{end_d:%Y%m%d}.xlsx" + out_path = ROOT / out_name + + wb = Workbook() + ws = wb.active + assert ws is not None + ws.title = "POWER BI 总信息" + + ws.append(HEADERS) + for row in build_rows(1000, rng, end_d): + ws.append(row) + + m_col = HEADERS.index("审核日期") + 1 + for r in range(2, 1002): + c = ws.cell(row=r, column=m_col) + if isinstance(c.value, date): + c.number_format = "YYYY-MM-DD" + + for j, _ in enumerate(HEADERS, start=1): + ws.column_dimensions[get_column_letter(j)].width = min(28, 12 + len(HEADERS[j - 1]) // 2) + + wb.save(out_path) + print(f"Written: {out_path}") + + +if __name__ == "__main__": + main() diff --git a/数据准备过程/模拟数据生成-提示词/generate_simulated_complaint.py b/数据准备过程/模拟数据生成-提示词/generate_simulated_complaint.py new file mode 100644 index 0000000..54562b5 --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/generate_simulated_complaint.py @@ -0,0 +1,254 @@ +# -*- coding: utf-8 -*- +"""按生成质量投诉模拟数据.md生成质量投诉模拟数据。""" + +from __future__ import annotations + +import random +from datetime import date, timedelta +from pathlib import Path + +from openpyxl import Workbook, load_workbook +from openpyxl.utils import get_column_letter + +ROOT = Path(__file__).resolve().parent +TEMPLATE = ROOT / "质量投诉数据-表头.xlsx" + +PRODUCTS = [ + { + "division": "输液治疗", + "bu": "IV Therapy BU", + "name": "一次性使用静脉留置针", + "models": ["20G", "22G", "24G", "Introcan Safety 20G"], + "faults": [ + ("渗漏", "使用中发现连接处渗液，影响持续输注"), + ("连接不牢", "与延长管连接后松动，需重复连接"), + ("流速异常", "滴速不稳定，出现间断性停止"), + ("包装破损", "开包前发现无菌包装破损"), + ], + "cases_max": 3, + }, + { + "division": "输液治疗", + "bu": "IV Therapy BU", + "name": "一次性使用输液器", + "models": ["IS-5.0", "IS-7.0", "PF-5.0"], + "faults": [ + ("堵塞", "输液过程中阻力升高，液体无法正常滴注"), + ("渗漏", "滴斗下方接口渗漏，需更换器械"), + ("标签不清", "批号标签印刷不清，追溯困难"), + ("流速异常", "调节轮无法稳定控制滴速"), + ], + "cases_max": 4, + }, + { + "division": "透析", + "bu": "Renal Care BU", + "name": "血液透析器", + "models": ["1.3m²", "1.4m²", "HD-180"], + "faults": [ + ("连接不牢", "血路连接后出现轻度渗血风险"), + ("断裂", "外壳边缘出现细微裂纹，已停止使用"), + ("流速异常", "跨膜压波动导致透析流程中断"), + ("包装破损", "透析器外包装密封不完整"), + ], + "cases_max": 2, + }, + { + "division": "透析", + "bu": "Renal Care BU", + "name": "血液透析管路", + "models": ["AV-SET-A", "AV-SET-P"], + "faults": [ + ("渗漏", "动脉端管路连接位出现渗液"), + ("堵塞", "泵管段阻力偏高触发报警"), + ("连接不牢", "静脉端接头锁定后仍可松脱"), + ], + "cases_max": 2, + }, + { + "division": "外科", + "bu": "Surgical BU", + "name": "可吸收性外科缝线", + "models": ["3-0", "4-0", "5-0"], + "faults": [ + ("断裂", "缝合过程中线体提前断裂"), + ("标签不清", "规格标签与实际颜色识别困难"), + ("包装破损", "单支包装封口松开，未使用"), + ], + "cases_max": 2, + }, +] + +HOSPITALS = [ + "上海市第一人民医院", + "浙江大学医学院附属第二医院", + "四川大学华西医院", + "广东省人民医院", + "中南大学湘雅医院", + "山东大学齐鲁医院", + "西安交通大学第一附属医院", + "南京鼓楼医院", + "福建省立医院", + "郑州大学第一附属医院", +] + +CONTACTS = ["张医生", "李护士长", "王老师", "陈医生", "赵工", "刘老师", "周护士"] +REPORTERS = ["设备科-赵工", "护理部-陈老师", "质控办-王老师", "临床工程-李工"] +MANUFACTURERS = [ + "贝朗医疗（上海）国际贸易有限公司", + "贝朗医疗（苏州）有限公司", + "贝朗爱敦（上海）医疗管理有限公司", +] +AE_NEG_REASONS = ["未造成患者伤害", "仅质量缺陷，无临床后果", "使用前发现缺陷，未接触患者"] +CONCLUSIONS = ["产品缺陷成立", "操作不当", "运输损伤", "未复现", "资料不足"] +PAYMENTS = ["无赔付", "换货", "折让", "退款", "其他协商处理"] +STATUS_POOL = ["新建", "调查中", "待补充", "已关闭"] + + +def rand_reg_no(rng: random.Random) -> str: + return f"国械注进20{rng.randint(15,26)}{rng.randint(100000,999999)}" + + +def rand_batch(rng: random.Random) -> str: + return f"{rng.choice('ABCDEFGH')}{rng.randint(1000000,9999999)}" + + +def rand_phone(rng: random.Random) -> str: + return f"1{rng.choice('3456789')}{rng.randint(100,999)}****{rng.randint(1000,9999)}" + + +def rand_serial(rng: random.Random, use_na: bool) -> str: + if use_na: + return "N/A" + return f"SN{rng.randint(10**9,10**10-1)}" + + +def choose_resolution(rng: random.Random, conclusion: str) -> tuple[str, str]: + if conclusion == "产品缺陷成立": + return "Replace", "更换同批次产品并加强到货检验" + if conclusion == "操作不当": + return "Training reinforced", "复测未见异常，建议规范操作培训" + if conclusion == "运输损伤": + return "Logistics improved", "判定为运输环节损伤，已优化包装与交付流程" + if conclusion == "未复现": + return "No defect found", "复测未见异常，建议持续观察后续批次" + return "Need more info", "现有证据不足，待补充样品及记录" + + +def generate_rows(n: int, seed: int) -> list[list]: + rng = random.Random(seed) + rows: list[list] = [] + today = date.today() + start = today - timedelta(days=980) + + for i in range(1, n + 1): + p = rng.choice(PRODUCTS) + fault, detail = rng.choice(p["faults"]) + hospital = rng.choice(HOSPITALS) + c3_date = start + timedelta(days=rng.randint(0, (today - start).days)) + c3_month = c3_date.strftime("%Y-%m") + + is_ae = "是" if rng.random() < 0.28 else "否" + ae_no_reason = "" if is_ae == "是" else rng.choice(AE_NEG_REASONS) + + status = rng.choices(STATUS_POOL, weights=[0.15, 0.25, 0.1, 0.5], k=1)[0] + report_done = None + closed_date = None + if status in ("调查中", "已关闭", "待补充"): + report_done = c3_date + timedelta(days=rng.randint(3, 45)) + if status == "已关闭": + base = report_done if report_done else c3_date + closed_date = base + timedelta(days=rng.randint(1, 30)) + + bad_qty = rng.randint(1, 20) + sample_return = "是" if rng.random() < 0.78 else "否" + if sample_return == "否": + qa_qty = 0 if rng.random() < 0.95 else rng.randint(0, bad_qty) + else: + qa_qty = rng.randint(1, bad_qty) + factory_qty = rng.randint(0, qa_qty) + case_count = 1 if rng.random() < 0.85 else rng.randint(2, p["cases_max"]) + + conclusion = rng.choice(CONCLUSIONS) + payment = rng.choice(PAYMENTS) + opinion_en, opinion_cn = choose_resolution(rng, conclusion) + + # make payment more coherent + if conclusion in ("未复现", "资料不足", "操作不当"): + payment = rng.choices(["无赔付", "其他协商处理", "折让"], weights=[0.7, 0.2, 0.1], k=1)[0] + elif conclusion == "产品缺陷成立": + payment = rng.choices(["换货", "退款", "折让", "无赔付"], weights=[0.5, 0.2, 0.2, 0.1], k=1)[0] + + row = [ + f"C3-{today:%Y}-{i:06d}", + rng.choice(p["models"]), + rand_batch(rng), + rand_serial(rng, use_na=("输液" in p["division"] and rng.random() < 0.6)), + rng.choice(MANUFACTURERS), + rand_reg_no(rng), + p["name"], + hospital, + rng.choice(CONTACTS), + rand_phone(rng), + fault, + detail, + rng.choice(REPORTERS), + p["bu"], + c3_date, + c3_month, + is_ae, + ae_no_reason, + bad_qty, + qa_qty, + factory_qty, + report_done, + opinion_en, + opinion_cn, + conclusion, + payment, + closed_date, + status, + sample_return, + p["division"], + case_count, + ] + rows.append(row) + return rows + + +def template_headers() -> list[str]: + wb = load_workbook(TEMPLATE, read_only=True, data_only=True) + ws = wb.active + headers = [ws.cell(1, j).value for j in range(1, ws.max_column + 1)] + wb.close() + return headers + + +def main() -> None: + headers = template_headers() + today = date.today() + out_path = ROOT / f"质量投诉数据-模拟1000条-{today:%Y%m%d}.xlsx" + rows = generate_rows(1000, int(today.strftime("%Y%m%d"))) + + wb = Workbook() + ws = wb.active + ws.title = "complaint form" + ws.append(headers) + for r in rows: + ws.append(r) + + # date columns + for r in range(2, 1002): + for col in ("O", "V", "AA"): + if ws[f"{col}{r}"].value: + ws[f"{col}{r}"].number_format = "YYYY-MM-DD" + + for i in range(1, len(headers) + 1): + ws.column_dimensions[get_column_letter(i)].width = 16 + + wb.save(out_path) + print(f"Written: {out_path}") + + +if __name__ == "__main__": + main() diff --git a/数据准备过程/模拟数据生成-提示词/generate_simulated_drug_ae_complaint.py b/数据准备过程/模拟数据生成-提示词/generate_simulated_drug_ae_complaint.py new file mode 100644 index 0000000..b597278 --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/generate_simulated_drug_ae_complaint.py @@ -0,0 +1,253 @@ +# -*- coding: utf-8 -*- +"""生成药品不良事件&投诉模拟数据（1000行）。""" + +from __future__ import annotations + +import random +from datetime import date, timedelta +from pathlib import Path + +from openpyxl import Workbook, load_workbook +from openpyxl.utils import get_column_letter + +ROOT = Path(__file__).resolve().parent +TEMPLATE = ROOT / "药品不良事件&投诉数据-表头.xlsx" + +CASE_OWNERS = ["PV专员-张", "PV专员-李", "药物警戒-王", "PV经理-陈"] +REPORTERS = ["销售-赵", "医学联络-周", "医院上报-吴", "客服-郑"] +INBOUND = ["电话", "邮件", "销售反馈", "医疗机构上报", "监管转入"] +FEEDBACK_CODE = ["有效", "待补充", "无效"] +FIRST_FOLLOW = ["首次", "跟踪"] +EXPECTED = ["预期", "非预期"] +REPORT_TYPE = ["自发报告", "文献", "上市后研究", "其他"] +SERIOUS = ["是", "否"] +UNIT_TYPE = ["三级医院", "二级医院", "基层医疗机构", "药店", "其他"] +SEX = ["男", "女"] +ETHNIC = ["汉族", "回族", "满族", "壮族", "苗族", "其他"] +BOOL_YN = ["是", "否"] +YN_UNK = ["是", "否", "不详", "未再用"] +INFO_SRC = ["医务人员", "患者", "文献", "监管机构", "公司主动收集"] +IMPORTANT_INFO = ["肝功能异常", "肾功能异常", "妊娠", "过敏体质", "其他", "无"] +SUSPECT_COMBI = ["怀疑药品", "合并用药"] +DOSAGE_UNITS = ["mg", "ml", "片", "粒", "支"] +FREQ = ["qd", "bid", "tid", "qod", "每周一次"] +ROUTE = ["口服", "静脉滴注", "肌内注射", "皮下注射"] + +DRUGS = [ + { + "approval": "国药准字H20103001", + "generic": "头孢呋辛酯片", + "brand": "新福辛", + "form": "片剂", + "mfg": "贝朗制药（苏州）有限公司", + "dose_range": (250, 500), + "dose_unit": "mg", + "route": "口服", + "indications": ["呼吸道感染", "泌尿系感染"], + }, + { + "approval": "国药准字H20153077", + "generic": "甲硝唑氯化钠注射液", + "brand": "美舒宁", + "form": "注射剂", + "mfg": "贝朗医疗制药（上海）有限公司", + "dose_range": (100, 250), + "dose_unit": "ml", + "route": "静脉滴注", + "indications": ["腹腔感染", "术后感染预防"], + }, + { + "approval": "国药准字H20064211", + "generic": "左氧氟沙星氯化钠注射液", + "brand": "利复宁", + "form": "注射剂", + "mfg": "贝朗医疗制药（上海）有限公司", + "dose_range": (100, 200), + "dose_unit": "ml", + "route": "静脉滴注", + "indications": ["肺部感染", "皮肤软组织感染"], + }, +] + +REACTIONS = [ + ("皮疹", "Skin and subcutaneous tissue disorders", "皮肤及皮下组织类疾病"), + ("恶心", "Gastrointestinal disorders", "胃肠系统疾病"), + ("呕吐", "Gastrointestinal disorders", "胃肠系统疾病"), + ("头晕", "Nervous system disorders", "神经系统疾病"), + ("肝功能异常", "Hepatobiliary disorders", "肝胆系统疾病"), + ("过敏反应", "Immune system disorders", "免疫系统疾病"), + ("注射部位反应", "General disorders and administration site conditions", "全身性疾病及给药部位各种反应"), +] + +RESULTS = ["痊愈", "好转", "未好转", "不详", "死亡"] +SEVERITY = ["轻度", "中度", "重度"] +CONCLUSION = ["可能有关", "很可能有关", "无法评价", "待随访"] +PROV_CITY_DIST = [ + ("上海市", "上海市", "浦东新区"), + ("浙江省", "杭州市", "西湖区"), + ("广东省", "广州市", "越秀区"), + ("四川省", "成都市", "武侯区"), + ("江苏省", "南京市", "鼓楼区"), + ("山东省", "济南市", "历下区"), +] + + +def template_headers() -> list[str]: + wb = load_workbook(TEMPLATE, read_only=True, data_only=True) + ws = wb.active + headers = [ws.cell(1, j).value for j in range(1, ws.max_column + 1)] + wb.close() + return headers + + +def rand_date(rng: random.Random, start: date, end: date) -> date: + return start + timedelta(days=rng.randint(0, (end - start).days)) + + +def make_row(i: int, rng: random.Random, today: date) -> list: + receipt = rand_date(rng, today - timedelta(days=900), today - timedelta(days=1)) + entry = receipt + timedelta(days=rng.randint(0, 3)) + submit = entry + timedelta(days=rng.randint(0, 5)) + report_ha = "是" if rng.random() < 0.85 else "否" + due_adr = receipt + timedelta(days=rng.randint(3, 15)) if report_ha == "是" else None + + first_follow = rng.choices(FIRST_FOLLOW, weights=[0.8, 0.2], k=1)[0] + serious_ae = rng.choices(SERIOUS, weights=[0.2, 0.8], k=1)[0] + + age = rng.randint(18, 85) + birth = receipt - timedelta(days=365 * age + rng.randint(0, 364)) + weight = round(rng.uniform(45, 95), 1) + + reaction_date = receipt - timedelta(days=rng.randint(0, 20)) + if reaction_date < today - timedelta(days=1200): + reaction_date = today - timedelta(days=1200) + + result = rng.choices(RESULTS, weights=[0.4, 0.35, 0.15, 0.08, 0.02], k=1)[0] + death_time = None + death_cause = None + if result == "死亡": + death_time = reaction_date + timedelta(days=rng.randint(0, 15)) + death_cause = rng.choice(["感染性休克", "呼吸衰竭", "多器官功能衰竭"]) + + has_hist = rng.random() < 0.28 + has_family = rng.random() < 0.2 + + react_cn, pt, soc = rng.choice(REACTIONS) + drug = rng.choice(DRUGS) + + med_start = reaction_date - timedelta(days=rng.randint(1, 30)) + med_days = rng.randint(1, 30) + med_end = med_start + timedelta(days=med_days - 1) + + serious_lv = "重度" if serious_ae == "是" else rng.choice(["轻度", "中度"]) + province, city, district = rng.choice(PROV_CITY_DIST) + + important = rng.choice(IMPORTANT_INFO) + important_other = "合并高脂血症" if important == "其他" else "" + + report_date = submit + timedelta(days=rng.randint(0, 5)) + + return [ + rng.choice(CASE_OWNERS), + rng.choice(REPORTERS), + rng.choice(INBOUND), + receipt, + entry, + report_ha, + due_adr, + f"AER-{today:%Y}-{i:06d}", + f"CC-{today:%Y}-{i:06d}", + submit, + rng.choice(FEEDBACK_CODE), + first_follow, + rng.choice(EXPECTED), + rng.choice(REPORT_TYPE), + serious_ae, + rng.choice(UNIT_TYPE), + rng.choice(SEX), + birth, + age, + "岁", + rng.choice(ETHNIC), + weight, + "有" if has_hist else "无", + "有" if has_family else "无", + reaction_date, + f"患者用药后出现{react_cn}，经对症处理后病情{'好转' if result!='死亡' else '加重'}。", + result, + "无" if result in ("痊愈", "好转") else ("轻度皮肤色素沉着" if result == "未好转" else ""), + death_time, + death_cause, + rng.choice(YN_UNK), + rng.choice(YN_UNK), + rng.choice(["无明显影响", "原患疾病短暂波动", "加重原患疾病"]), + rng.choice(CONCLUSION), + rng.choice(CONCLUSION), + report_date, + rng.choice(INFO_SRC), + "模拟数据，仅用于分析演示", + rng.choice(drug["indications"]), + react_cn if has_family else "", + rng.choice([d["brand"] for d in DRUGS]) if has_family else "", + rng.choice(SEVERITY) if has_family else "", + react_cn if has_hist else "", + rng.choice(SEVERITY) if has_hist else "", + rng.choice([d["brand"] for d in DRUGS]) if has_hist else "", + important, + important_other, + rng.choices(SUSPECT_COMBI, weights=[0.7, 0.3], k=1)[0], + 1, + drug["approval"], + drug["generic"], + drug["brand"], + drug["form"], + drug["mfg"], + f"{rng.choice('ABCDEFGH')}{rng.randint(100000,999999)}", + round(rng.uniform(*drug["dose_range"]), 1), + drug["dose_unit"] if rng.random() < 0.85 else rng.choice(DOSAGE_UNITS), + rng.choice(FREQ), + med_days, + drug["route"] if rng.random() < 0.85 else rng.choice(ROUTE), + med_start, + med_end, + rng.choice(drug["indications"]), + react_cn, + serious_lv, + pt, + soc, + province, + city, + district, + ] + + +def main() -> None: + headers = template_headers() + today = date.today() + rng = random.Random(int(today.strftime("%Y%m%d"))) + out = ROOT / f"药品不良事件&投诉数据-模拟1000条-{today:%Y%m%d}.xlsx" + + wb = Workbook() + ws = wb.active + ws.title = "Tabelle1" + ws.append(headers) + + for i in range(1, 1001): + ws.append(make_row(i, rng, today)) + + # date formats + date_cols = [4, 5, 7, 10, 18, 25, 29, 36, 61, 62] + for r in range(2, 1002): + for c in date_cols: + v = ws.cell(r, c).value + if isinstance(v, date): + ws.cell(r, c).number_format = "YYYY-MM-DD" + for i in range(1, len(headers) + 1): + ws.column_dimensions[get_column_letter(i)].width = 15 + + wb.save(out) + print(f"Written: {out}") + + +if __name__ == "__main__": + main() diff --git a/数据准备过程/模拟数据生成-提示词/生成不良事件模拟数据.md b/数据准备过程/模拟数据生成-提示词/生成不良事件模拟数据.md new file mode 100644 index 0000000..cbb5ea5 --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/生成不良事件模拟数据.md @@ -0,0 +1,146 @@ +生成不良事件模拟数据 + +# 角色与目标 + +你是数据分析助手。请根据本地 Excel 表头，生成 1000 条「贝朗（B. Braun）相关产品」的模拟不良事件数据（仅用于内部分析、培训或演示，非真实上报数据），并导出为新的 Excel 文件。 + +# 1. 输入文件（必须先读） + +路径：贝朗数据/不良事件数据-表头.xlsx（若工作区根目录不同，以用户提供的「贝朗数据」文件夹为准）。 + +| 列 | 字段名 | +|----|--------| +| A | 报告编码 | +| B | CC | +| C | 单位名称 | +| D | 事业线 | +| E | 产品名称 | +| F | 注册证编号/曾用注册证编号 | +| G | 注册人 | +| H | 型号 | +| I | 产品批号 | +| J | 伤害 | +| K | 伤害表现 | +| L | 器械故障表现 | +| M | 审核日期 | + +工作表名：**POWER BI 总信息**（与源文件一致）。 + +# 2. 各列填充规则（A–M） + +以下规则适用于第 2–1001 行数据行；第 1 行为表头，不得改动列名与列顺序。 + +## A 列「报告编码」 + +- 1000 条记录**互不重复**。 +- 格式建议：`SIM-年份-6 位序号`（如 `SIM-2024-000001`～`SIM-2024-001000`）；若源表头文件中有示例编码，优先与示例**风格一致**。 +- 仅作模拟数据集主键，**不代表**任何真实上报编号。 + +## B 列「CC」 + +- 表示投诉/反馈渠道或分类的简短标签（具体含义可按内部分类理解）。 +- 从有限**枚举池**中抽取并轮换使用，例如：`质量反馈`、`临床使用`、`包装标识`、`灭菌外观`、`物流储运`、`培训咨询`、`不良事件` 等；可酌情增减，但须**全表多样化**，避免 1000 行几乎同一取值。 +- 取值风格统一为**简短中文短语**，勿使用空值占位。 + +## C 列「单位名称」 + +- 填写**医疗机构或报告单位**风格的全称（如「××大学附属××医院」「××省人民医院」等）。 +- 覆盖**多个省份/城市**，名称不雷同；可混合三甲、肿瘤专科、大学附属医院等，增强分布真实感。 +- **勿**使用真实在世的具体科室或个人姓名；机构名可与公开信息风格相近，整体仍为**合成**。 + +## D 列「事业线」 + +- 与 **E 列产品名称**严格对应：每条记录的事业线必须是该产品所属业务板块（如输液治疗、透析产品、外科产品、诊断/监测耗材等）。 +- 使用**统一、有限**的事业线名称集合，避免同一产品线出现多种写法（如不要同时出现「透析」与「透析产品线」两种未规范写法）。 +- 禁止出现与 E 列**明显矛盾**的组合（例如事业线为透析而产品名称为静脉留置针）。 + +## E 列「产品名称」 + +- 先检索并整理「贝朗（B. Braun）在中国境内已上市医疗器械」的**代表性产品清单**（优先依据：国家药监局 NMPA 公开数据、贝朗中国官网/说明书中的产品名、行业常见命名习惯）。 +- 若无法保证 100% 与备案/注册信息一致，须在交付说明中明确标注：**「产品名为基于公开信息的归纳与模拟，不用于法规申报」**。 +- **只能**使用该清单中的名称；1000 条中多个产品按**合理比例**分布（不必均匀，可模拟销量/用量结构，如留置针、输液器占比可高于小众型号）。 + +## F 列「注册证编号/曾用注册证编号」 + +- 风格与境内医疗器械注册证号**格式相近**（如 `国械注进20××××××`、`国械注准201××××××` 等），**可为虚构**，不要求与真实证号一一对应。 +- 同一产品名称（E）下可出现**多条不同证号**（曾用证、换证等场景），但须避免全表仅 1～2 个证号来回复制。 +- **禁止**在交付物中声称「本列与 NMPA 公示完全一致」。 + +## G 列「注册人」 + +- 填写与**贝朗在华主体**命名风格一致的注册人/备案人名称，例如：`贝朗医疗（上海）国际贸易有限公司`、`贝朗爱敦（上海）医疗管理有限公司`、`贝朗医疗（苏州）有限公司` 等（可从公开信息归纳固定枚举池）。 +- 从枚举池中**加权或随机轮换**，避免 1000 行全部为同一字符串。 +- 注册人可与 E 列产品线有**常识性对应**（不必逐条严格考证），整体保持可信。 + +## H 列「型号」 + +- 与 **E 列具体产品**匹配：每条记录的型号应像该产品在说明书或标签上会出现的规格/型号写法（含规格代码、Gauge、容量等）。 +- 同一 E 列产品可对应**多个型号**，在 1000 条中分散出现。 +- 避免全表型号重复率过高；**勿**编造与该产品类别完全无关的型号描述。 + +## I 列「产品批号」 + +- 模拟生产批号：字母与数字组合（如 `A7382912`、`H9210045`），长度与风格在**合理区间**内波动。 +- **每条尽量不同**；允许极低概率的「同批号不同报告」以模拟聚集性，但不应成为主流。 +- 不使用明显无效占位（如 `TEST`、`111111` 连续大量出现）。 + +## J 列「伤害」 + +- 简明表示是否造成伤害或伤害分级习惯用语，须与真实上报字段定义**在风格上兼容**；常见写法如：`是`、`否`、`不详` 等（若源系统仅有「是/否」，则不要使用三级分类）。 +- **必须与 K、L 列逻辑一致**：若 L 为严重器械故障而 K 为重伤表现，则 J 一般不应为「否」；避免三列自相矛盾。 +- 作为模拟，所有数据，J列均为 是。 + +## K 列「伤害表现」 + +- 用**简短中文**描述临床表现或患者主诉，与 **J 列**及器械使用场景相符。 +- 无伤害时可为「无」或与 J=否 一致的轻描述；有伤害时描述**程度与部位**宜多样化（红肿、出血、血肿、低血压、头痛等），避免千行同一句话，伤害表现应该符合医学术语表达规范，如使用WHOART医学术语。 +- 措辞偏**临床记录体**，避免小说式长段落。 +- 作为模拟，我们需要所有数据都包括 伤害表现。 + + +## L 列「器械故障表现」 + +- 描述**器械本身**的异常或失效表现，与 **E 列产品类别**强相关（见下节示例维度）。 +- 与 **J、K** 形成因果或并列关系合理：如渗漏、堵塞、压力异常、固定失效、裂纹、连接不牢等。 +- 同类别产品在句式上**变换同义词与细节**，避免模板化重复。 + +## M 列「审核日期」 + +- 落在近 **24～36 个月**内的日期范围；优先使用**工作日**（周一至周五），减少全体落在周末的不自然分布。 +- Excel 中保存为**日期型**（非纯文本），显示格式可与源表头文件一致（如 `YYYY-MM-DD`）。 +- 全表日期应有一定**随机分散**，避免集中为同一天或呈完全规律递增。 + +# 3. 真实感与「产品—事件」关联（核心，与第 2 节配合） + +- **D、E、H** 三位一体：事业线、产品名、型号须为同一叙事下的器械信息。 +- **J、K、L** 须与产品类别逻辑一致，例如： + - **输液/输注类**：渗漏、堵塞、流速异常、管路打折/断裂、接头不牢、排气问题等； + - **透析类**：跨膜压/电导度异常、管路渗血渗液、透析器外壳问题、液面异常等； + - **外科/缝线类**：线结滑脱、缝针异常、异物感、固定或粘贴失效等。 +- **C 列**可间接体现场景（大型综合医院、肿瘤中心等），与产品使用场景不冲突。 +- 避免每条记录使用**完全相同**的 K/L 模板句；在同类别内替换措辞、程度与发现环节。 + +# 4. 输出 + +新建 Excel 文件，保存到 **贝朗数据** 文件夹下。 +建议文件名：`不良事件数据-模拟1000条-YYYYMMDD.xlsx`（日期为生成当日）。 +工作表名仍为 **POWER BI 总信息**；第 1 行为原表头，第 2–1001 行为数据。 +列顺序与列名与源表头文件**完全一致**，便于后续 Power BI 或透视表使用。 + +# 5. 交付时请用文字简要说明 + +- 产品清单主要依据哪些公开来源（或说明为归纳模拟）。 +- 各事业线/主要产品的大致条数占比。 +- **明确声明**：本文件为**合成数据**，不代表现实中的不良事件报告。 + +--- + +## 附：文档结构说明（供执行方自检） + +| 维度 | 说明 | +|------|------| +| 结构 | 已写明工作表名与 13 个字段及**逐列填充规则**，避免猜列或错位。 | +| E 列 | 要求检索路径 + 无法核验时的声明，降低「虚构产品名却被当作事实」的风险。 | +| 真实性 | 各列规则 + 第 3 节跨列关联，保证 J/K/L 与产品线一致及字段多样化。 | +| 输出 | 固定行数（2–1001）、命名规则、路径明确。 | +| 合规 | 强调合成数据用途，避免误用作正式上报。 | diff --git a/数据准备过程/模拟数据生成-提示词/生成入院量模拟数据.md b/数据准备过程/模拟数据生成-提示词/生成入院量模拟数据.md new file mode 100644 index 0000000..2fa513f --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/生成入院量模拟数据.md @@ -0,0 +1,201 @@ +生成入院量模拟数据 + +# 角色与目标 + +你是数据分析助手。请根据本地 Excel 表头，生成 1000 条「贝朗（B. Braun）产品在医院端入院/使用相关业务口径」的模拟数据（仅用于内部分析、培训或演示，非真实经营报表数据），并导出为新的 Excel 文件。 + +# 1. 输入文件（必须先读） + +路径：`贝朗数据/入院量-表头.xlsx`（若工作区根目录不同，以用户提供的「贝朗数据」文件夹为准）。 + +| 列 | 字段名 | +|----|--------| +| A | Year | +| B | Month | +| C | HospitalName | +| D | HospitalCode | +| E | DealerName | +| F | DealerCode | +| G | Province | +| H | City | +| I | GlobalDivision | +| J | LocalDivision | +| K | BU | +| L | ProductLine | +| M | ProductLineType | +| N | Material | +| O | MaterialDesc | +| P | CY Amt | +| Q | LY Amt | +| R | Growth Amt | +| S | Growth% Amt | +| T | CY Qty | +| U | LY Qty | +| V | Growth Qty | +| W | Growth% Qty | +| X | CY LE AMT | + +工作表名：`Sheet1`（与源文件一致）。 + +# 2. 各列填充规则（A–X） + +以下规则适用于第 2–1001 行数据行；第 1 行为表头，不得改动列名与列顺序。 + +## A 列 `Year` + +- 建议取近 2～3 年（如 `2024`、`2025`、`2026`）的整数年份。 +- 与 B 列 `Month` 组合后应形成合理时间分布，避免 1000 条全部落在同一年同一月。 + +## B 列 `Month` + +- 取值范围 `1`～`12`（整数）。 +- 与 A 列匹配，允许季节性波动（如 Q4 数值略高）但不要机械重复。 + +## C 列 `HospitalName` + +- 采用中国境内医院全称风格（如「××大学附属××医院」「××省人民医院」）。 +- 与 G/H（省/市）保持一致，避免城市与医院明显冲突。 +- 全表使用多个医院，避免极端集中到单家医院。 + +## D 列 `HospitalCode` + +- 为 `HospitalName` 的稳定唯一编码（同一医院编码必须一致）。 +- 格式建议：`H` + 5～8 位数字或字母数字组合（如 `H310001`）。 +- 不同医院不得复用同一编码。 + +## E 列 `DealerName` + +- 使用经销商/渠道商公司名称风格（如「××医疗器械有限公司」「××医药科技有限公司」）。 +- 同一医院可出现多个经销商；同一经销商也可服务多个医院。 + +## F 列 `DealerCode` + +- 为 `DealerName` 的稳定唯一编码（同名同码、异名异码）。 +- 格式建议：`D` + 4～8 位数字（如 `D10258`）。 + +## G 列 `Province` + +- 省级行政区名称（如 `上海市`、`浙江省`、`广东省`）。 +- 必须与 H 列 `City` 形成真实的省市归属关系。 + +## H 列 `City` + +- 地级市/直辖市名称（如 `上海市`、`杭州市`、`广州市`）。 +- 与 C 列医院所在地、G 列省份一致。 + +## I 列 `GlobalDivision` + +- 使用有限枚举值，建议按全球业务大类，如 `Hospital Care`、`Aesculap`、`Avitum`。 +- 与 J/K/L/M 保持层级逻辑一致，不要跨事业部乱配。 + +## J 列 `LocalDivision` + +- 中国本地事业部分组名称（如 `输液治疗`、`外科`、`透析`）。 +- 与 I 列映射稳定（同一 LocalDivision 不要映射到多个互斥 GlobalDivision）。 + +## K 列 `BU` + +- 业务单元名称（如 `IV Therapy BU`、`Renal Care BU`、`Surgical BU`）。 +- 与 J/L 保持业务口径一致，避免出现不相关组合。 + +## L 列 `ProductLine` + +- 产品线名称（如 `静脉输注`、`透析耗材`、`缝线与外科耗材`）。 +- 与 M/N/O 联动：同一产品线应对应合理的物料与描述。 + +## M 列 `ProductLineType` + +- 产品线子类型（如 `输液器`、`留置针`、`透析器`、`缝线`）。 +- 建议作为 L 列的细分层，不可脱离 L 列独立随机。 + +## N 列 `Material` + +- 物料编码，建议使用稳定格式（如 `MAT` + 6 位数字，例 `MAT203145`）。 +- 同一 O 列 `MaterialDesc` 对应固定 Material 编码。 +- 不同物料编码应可重复出现（代表多月或多医院销售/入院量）。 + +## O 列 `MaterialDesc` + +- 物料中文描述，体现规格和品类信息（如「一次性使用静脉留置针 20G」）。 +- 与 M/N 严格一致，避免一个编码对应多种冲突描述。 + +## P 列 `CY Amt` + +- 当年金额（Current Year Amount），数值型，建议保留 2 位小数。 +- 取值必须非负；建议以业务真实感设置在合理范围（如几千到几十万不等）。 + +## Q 列 `LY Amt` + +- 去年同期金额（Last Year Amount），数值型，建议保留 2 位小数。 +- 允许部分记录为 0（新品/新医院场景），但比例不宜过高（建议 <10%）。 + +## R 列 `Growth Amt` + +- 由公式逻辑生成：`Growth Amt = CY Amt - LY Amt`。 +- 应与 P/Q 精确一致，不可独立随机。 + +## S 列 `Growth% Amt` + +- 由公式逻辑生成：当 `LY Amt > 0` 时，`Growth% Amt = Growth Amt / LY Amt`。 +- 当 `LY Amt = 0` 时，可统一规则为 `0` 或空值，且需在交付说明中说明处理口径。 +- 建议保留 4 位小数或百分比显示格式（如 `0.1234` 对应 `12.34%`）。 + +## T 列 `CY Qty` + +- 当年数量（Current Year Quantity），整数型（建议 >=0）。 +- 与 P 列金额保持大致单价一致（同一物料单价波动不应过大）。 + +## U 列 `LY Qty` + +- 去年同期数量，整数型（建议 >=0）。 +- 可少量为 0（新品导入场景），但应与 Q 列口径一致。 + +## V 列 `Growth Qty` + +- 由公式逻辑生成：`Growth Qty = CY Qty - LY Qty`。 +- 应与 T/U 严格一致。 + +## W 列 `Growth% Qty` + +- 由公式逻辑生成：当 `LY Qty > 0` 时，`Growth% Qty = Growth Qty / LY Qty`。 +- 当 `LY Qty = 0` 时按统一口径处理（0 或空值），并在交付说明注明。 + +## X 列 `CY LE AMT` + +- 当年预计金额（Latest Estimate Amount），数值型，建议保留 2 位小数。 +- 与 P 列相关但不应完全相同；建议围绕 `CY Amt` 在合理区间波动（如 `0.9x`～`1.15x`）。 +- 禁止出现明显异常值（如负数、极端大值）破坏整体分布。 + +# 3. 真实感与跨列关联（核心，与第 2 节配合） + +- 组织维度关联：`HospitalName/HospitalCode`、`DealerName/DealerCode` 必须一一稳定映射。 +- 地理维度关联：`Province/City/HospitalName` 三列一致，不得出现跨省错配。 +- 产品维度关联：`GlobalDivision → LocalDivision → BU → ProductLine → ProductLineType → Material → MaterialDesc` 需层级一致。 +- 指标维度关联：`Growth Amt` 与 `Growth% Amt` 由金额推导；`Growth Qty` 与 `Growth% Qty` 由数量推导，不能脱离基础值随机填。 +- 经营合理性：金额与数量保持可解释的单价区间；避免同一物料在相邻月份出现无理由 10 倍跳变。 + +# 4. 输出 + +新建 Excel 文件，保存到 `贝朗数据` 文件夹下。 +建议文件名：`入院量数据-模拟1000条-YYYYMMDD.xlsx`（日期为生成当日）。 +工作表名仍为 `Sheet1`；第 1 行为原表头，第 2–1001 行为数据。 +列顺序与列名与源表头文件完全一致，便于后续 Power BI 或透视分析使用。 + +# 5. 交付时请用文字简要说明 + +- 组织维度（医院、经销商）与产品维度（事业部、产品线、物料）的生成口径。 +- 金额/数量及增长率字段的计算口径（尤其 LY=0 时的处理规则）。 +- 各年度、主要产品线、主要省份的数据占比概览。 +- 明确声明：本文件为合成数据，不代表真实业务入院量或销售数据。 + +--- + +## 附：执行自检清单 + +| 检查项 | 合格标准 | +|------|------| +| 行数 | 总行数为 1001（含表头），数据行 1000。 | +| 列结构 | 24 列列名与顺序与 `入院量-表头.xlsx` 完全一致。 | +| 编码一致性 | 同一医院/经销商/物料名称对应唯一编码，不发生混码。 | +| 计算一致性 | R/S/V/W 与 P/Q/T/U 计算逻辑一致，无公式冲突。 | +| 业务合理性 | 省市医院匹配、产品层级匹配、金额数量分布无明显异常。 | diff --git a/数据准备过程/模拟数据生成-提示词/生成药品不良事件&投诉模拟数据.md b/数据准备过程/模拟数据生成-提示词/生成药品不良事件&投诉模拟数据.md new file mode 100644 index 0000000..d757dac --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/生成药品不良事件&投诉模拟数据.md @@ -0,0 +1,181 @@ +生成药品不良事件&投诉模拟数据 + +# 角色与目标 + +你是数据分析助手。请根据本地 Excel 表头，生成 1000 条「药品不良事件与投诉」模拟数据（仅用于内部分析、培训或演示，非真实药物警戒上报数据），并导出为新的 Excel 文件。 + +# 1. 输入文件（必须先读） + +路径：`贝朗数据/药品不良事件&投诉数据-表头.xlsx`（若工作区根目录不同，以用户提供的「贝朗数据」文件夹为准）。 + +工作表名：`Tabelle1`（与源文件一致）。 + +表头共 70 列，必须严格保持列名与顺序不变（第 1 行原样保留）： + +| 序号 | 字段名 | +|---|---| +| 1 | Case owner | +| 2 | reporter | +| 3 | Inbound Channel | +| 4 | Local PV ReceiptDate（含原表头换行说明） | +| 5 | Initial data entry date | +| 6 | Reportability to HA | +| 7 | Due Date to ADR Center | +| 8 | AER# | +| 9 | CC# | +| 10 | Submit date | +| 11 | 反馈码 | +| 12 | 首次/跟踪报告 | +| 13 | 预期/非预期 | +| 14 | 报告类型 | +| 15 | 严重不良反应 | +| 16 | 报告单位类别 | +| 17 | 性别 | +| 18 | 出生日期 | +| 19 | 年龄 | +| 20 | 年龄单位 | +| 21 | 民族 | +| 22 | 体重 | +| 23 | 既往药品不良反应 | +| 24 | 家族药品不良反应 | +| 25 | 不良反应发生时间 | +| 26 | 不良反应过程描述 | +| 27 | 不良反应结果 | +| 28 | 后遗症表现 | +| 29 | 死亡时间 | +| 30 | 直接死因 | +| 31 | 停药减药后反应是否减轻或消失 | +| 32 | 再次使用可疑药是否出现同样反应 | +| 33 | 对原患疾病影响 | +| 34 | 报告人评价 | +| 35 | 报告单位评价 | +| 36 | 报告日期 | +| 37 | 信息来源 | +| 38 | 备注 | +| 39 | 原患疾病名称 | +| 40 | 家族药品不良反应[不良反应名称] | +| 41 | 家族药品不良反应[商品名称] | +| 42 | 家族药品不良反应[严重程度] | +| 43 | 既往药品不良反应[不良反应名称] | +| 44 | 既往药品不良反应[严重程度] | +| 45 | 既往药品不良反应[商品名称] | +| 46 | 相关重要信息 | +| 47 | 相关重要信息(其他) | +| 48 | 怀疑/合并 | +| 49 | 序号 | +| 50 | 批准文号 | +| 51 | 通用名称 | +| 52 | 商品名称 | +| 53 | 剂型 | +| 54 | 生产厂家 | +| 55 | 生产批号 | +| 56 | 用量 | +| 57 | 用量单位 | +| 58 | 用药-次数 | +| 59 | 用药-日数 | +| 60 | 给药途径 | +| 61 | 用药开始时间 | +| 62 | 用药结束时间 | +| 63 | 用药原因 | +| 64 | 不良反应名称 | +| 65 | 严重程度 | +| 66 | 不良反应名称（PT） | +| 67 | 不良反应名称（SOC） | +| 68 | 省 | +| 69 | 市 | +| 70 | 区 | + +# 2. 各列填充规则（1–70） + +以下规则适用于第 2–1001 行；第 1 行为原表头，不得改动。 + +## A. 病例流转与时效字段（1–11） + +- `Case owner`、`reporter`：使用岗位化姓名（匿名化），格式统一，避免真实个人敏感信息。 +- `Inbound Channel`：枚举值（如 `电话`、`邮件`、`销售反馈`、`医疗机构上报`、`监管转入`）。 +- 日期逻辑必须满足： + `Local PV ReceiptDate <= Initial data entry date <= Submit date`。 + 若 `Reportability to HA=是`，则 `Due Date to ADR Center` 必填，且应晚于 `ReceiptDate`。 +- `AER#`、`CC#`：各自唯一编码，建议格式如 `AER-YYYY-000001`、`CC-YYYY-000001`。 +- `反馈码`：有限枚举（如 `有效`、`无效`、`待补充`）。 + +## B. 报告属性与患者基本信息（12–24） + +- `首次/跟踪报告`：枚举 `首次`、`跟踪`，若为跟踪，`AER#` 应复用同案例主编号规则。 +- `预期/非预期`、`报告类型`、`严重不良反应`、`报告单位类别`使用固定枚举，避免自由文本混乱。 +- 患者信息联动：`出生日期`、`年龄`、`年龄单位`必须可互相解释（允许有轻微误差）；`体重`为数值型并在合理区间。 +- `既往药品不良反应`、`家族药品不良反应`与其展开字段（40–45）保持一致：若主字段为“无”，对应展开字段应空或 `N/A`。 + +## C. 反应发生与医学结局（25–38） + +- `不良反应发生时间`应晚于或等于 `用药开始时间`（若有）。 +- `不良反应过程描述`为中文临床叙述，简洁、可读、与药品信息一致。 +- `不良反应结果`、`后遗症表现`、`死亡时间`、`直接死因`联动： + - 非死亡病例：`死亡时间/直接死因`应为空； + - 死亡病例：`严重程度`应为重度相关，且死因可解释。 +- `停药减药后反应是否减轻或消失`、`再次使用可疑药是否出现同样反应`使用标准枚举（是/否/不详/未再用）。 +- `报告人评价`与`报告单位评价`给出一致但不完全重复的专业结论文本。 +- `报告日期`通常晚于 `不良反应发生时间`。 +- `信息来源`、`备注`可补充场景，但不得出现真实可识别隐私信息。 + +## D. 既往/家族史扩展与重要信息（39–47） + +- `原患疾病名称`使用规范疾病名（示例：高血压、糖尿病、慢性肾病等）。 +- 家族史与既往史展开字段（40–45）建议结构化填写： + - 不良反应名称 + - 涉及商品名称 + - 严重程度 +- `相关重要信息`可枚举（如 `肝功能异常`、`肾功能异常`、`妊娠`、`过敏体质`、`其他`）； + 若为`其他`，`相关重要信息(其他)`必须填写。 + +## E. 用药信息子表（48–63） + +- `怀疑/合并`：枚举 `怀疑药品`、`合并用药`，至少有一条怀疑药品记录。 +- `序号`：同一病例内递增序号（若每行仅1药，可统一为 1）。 +- `批准文号`、`通用名称`、`商品名称`、`剂型`、`生产厂家`、`生产批号`需互相匹配且风格真实；文号可模拟但格式需合理。 +- `用量`为数值，`用量单位`（mg/ml/片等）与剂型匹配。 +- `用药-次数`、`用药-日数`与`用药开始/结束时间`可互相解释（结束时间应不早于开始时间）。 +- `给药途径`（口服/静脉滴注/皮下/肌注等）需与药品剂型和反应场景匹配。 +- `用药原因`与`原患疾病名称`存在医学关联。 + +## F. 不良反应标准术语与地区字段（64–70） + +- `不良反应名称`使用中文医学术语；`不良反应名称（PT）`、`（SOC）`与其对应（可参考 MedDRA 术语风格）。 +- `严重程度`与上文 `严重不良反应`一致，不得矛盾。 +- `省/市/区`三级行政区必须逻辑一致，不跨省错配；可与报告单位地理分布相匹配。 + +# 3. 真实感与跨列关联（核心） + +- **时间链路闭环**：获知日期、录入日期、上报日期、发生日期、用药起止日期必须前后合理。 +- **医学逻辑闭环**：可疑药品 -> 用药信息 -> 不良反应名称/PT/SOC -> 严重程度 -> 结局描述应一致。 +- **结构化字段闭环**：主字段与展开字段（既往史、家族史、重要信息）不冲突。 +- **编码唯一性**：`AER#` 和 `CC#` 全表唯一；若设计跟踪报告，应保持主案例可追踪。 +- **文本去模板化**：过程描述和评价需同类可变体，不得 1000 条高度重复同一句。 + +# 4. 输出 + +新建 Excel 文件，保存到 `贝朗数据` 文件夹下。 +建议文件名：`药品不良事件&投诉数据-模拟1000条-YYYYMMDD.xlsx`（日期为生成当日）。 +工作表名仍为 `Tabelle1`；第 1 行为原表头，第 2–1001 行为数据。 +列顺序与列名与源表头文件完全一致（包括原始表头中的换行字符）。 + +# 5. 交付时请用文字简要说明 + +- 病例来源渠道、报告类型、严重程度的大致分布口径。 +- 用药信息与反应术语（PT/SOC）的映射口径与来源说明（如为归纳模拟需明确说明）。 +- 日期与状态字段的约束规则（尤其上报时限字段）。 +- 明确声明：本文件为合成数据，不代表真实药物警戒病例或监管上报记录。 + +--- + +## 附：执行自检清单 + +| 检查项 | 合格标准 | +|---|---| +| 行数 | 总行数 1001（含表头），数据行 1000。 | +| 列结构 | 70 列列名与顺序与 `药品不良事件&投诉数据-表头.xlsx` 完全一致。 | +| 编码规则 | `AER#`、`CC#` 唯一；跟踪报告可追踪。 | +| 时间逻辑 | 关键日期前后关系正确，无明显逆序。 | +| 术语一致 | 反应中文名、PT、SOC、严重程度互相匹配。 | +| 字段联动 | 主字段与展开字段（既往史/家族史/重要信息）一致。 | +| 合规脱敏 | 不出现真实可识别个人电话和身份信息。 | diff --git a/数据准备过程/模拟数据生成-提示词/生成质量投诉模拟数据.md b/数据准备过程/模拟数据生成-提示词/生成质量投诉模拟数据.md new file mode 100644 index 0000000..f7a4db2 --- /dev/null +++ b/数据准备过程/模拟数据生成-提示词/生成质量投诉模拟数据.md @@ -0,0 +1,242 @@ +生成质量投诉模拟数据 + +# 角色与目标 + +你是数据分析助手。请根据本地 Excel 表头，生成 1000 条「贝朗（B. Braun）产品质量投诉」模拟数据（仅用于内部分析、培训或演示，非真实投诉记录），并导出为新的 Excel 文件。 + +# 1. 输入文件（必须先读） + +路径：`贝朗数据/质量投诉数据-表头.xlsx`（若工作区根目录不同，以用户提供的「贝朗数据」文件夹为准）。 + +| 列 | 字段名 | +|----|--------| +| A | C3编号 | +| B | 型号 | +| C | 批号 | +| D | 序列号 | +| E | 生产企业名称 | +| F | 注册证号 | +| G | 产品名称 | +| H | 医院名称 | +| I | 投诉联系人 | +| J | 联系人电话 | +| K | 故障类型 | +| L | 投诉详情（中文） | +| M | 上报人 | +| N | BU | +| O | C3登记日期 | +| P | C3登记月 | +| Q | 是否不良事件 | +| R | 不良事件（否） | +| S | 上报坏品数量 | +| T | 坏品退回QA数量 | +| U | A退回原厂数量 | +| V | 调查报告完成日期 | +| W | 调查报告（处理意见） | +| X | 调查报告中文（处理意见） | +| Y | 调查结论（处理结果） | +| Z | 赔付结论 | +| AA | 关闭日期 | +| AB | 投诉状态 | +| AC | 有样品返回 | +| AD | 事业部 | +| AE | 例数 | + +工作表名：`complaint form`（与源文件一致）。 + +# 2. 各列填充规则（A–AE） + +以下规则适用于第 2–1001 行数据行；第 1 行为表头，不得改动列名与列顺序。 + +## A 列 `C3编号` + +- 1000 条记录必须唯一。 +- 格式建议：`C3-YYYY-6位序号`（如 `C3-2026-000001`）。 +- 若源系统存在固定前缀规则，优先匹配该风格。 + +## B 列 `型号` + +- 与 G 列 `产品名称`严格匹配，采用医疗器械常见型号表达（含规格代码、尺寸、Gauge 等）。 +- 同一产品名称应对应多个型号，避免全表单一型号。 + +## C 列 `批号` + +- 字母数字组合（如 `A7429158`），长度风格统一。 +- 允许低比例重复（同批次多例投诉），但不可大面积重复。 + +## D 列 `序列号` + +- 对于有唯一序列号管理的设备/器械填写唯一值；耗材类可用空值或 `N/A`（需统一口径）。 +- 若填写，建议格式：`SN` + 8～12 位字符。 + +## E 列 `生产企业名称` + +- 使用贝朗相关主体或生产方命名风格（如贝朗医疗相关公司名）。 +- 与产品线存在常识性匹配，避免明显冲突。 + +## F 列 `注册证号` + +- 使用与 NMPA 注册证号风格一致的格式（可虚构，但格式合理）。 +- 可出现历史证号/曾用证号场景，但不得宣称与真实公示逐条一致。 + +## G 列 `产品名称` + +- 基于贝朗在中国常见产品线归纳（输液、透析、外科等）并保持可解释性。 +- 与 B/K/AD 等列保持逻辑一致。 + +## H 列 `医院名称` + +- 采用中国境内医院全称风格，覆盖多个省市和层级医院。 +- 与投诉场景合理匹配，不出现明显虚构乱码名称。 + +## I 列 `投诉联系人` + +- 使用匿名化中文姓名（如“张医生”“李护士长”或“王老师”），避免真实个人敏感信息。 +- 可重复但不宜全表高度重复。 + +## J 列 `联系人电话` + +- 使用脱敏规则生成（如 `138****5621`）或模拟号段（11 位手机格式）。 +- 禁止真实可识别电话号码。 + +## K 列 `故障类型` + +- 使用有限枚举值，如：`渗漏`、`堵塞`、`断裂`、`连接不牢`、`包装破损`、`标签不清`、`流速异常` 等。 +- 与 G/L 语义一致。 + +## L 列 `投诉详情（中文）` + +- 用简洁中文描述现场问题、发现环节、初步影响。 +- 必须与 K 列故障类型一致，避免“类型-详情”冲突。 + +## M 列 `上报人` + +- 使用医院端岗位化称谓（如“设备科-赵工”“护理部-陈老师”）或匿名姓名。 +- 与 H/I 保持合理关联。 + +## N 列 `BU` + +- 业务单元枚举（如 `IV Therapy BU`、`Renal Care BU`、`Surgical BU`）。 +- 与 G/AD 产品事业线一致。 + +## O 列 `C3登记日期` + +- 日期型字段，建议覆盖近 24～36 个月。 +- 需早于或等于 V 列、AA 列对应日期（若后两者非空）。 + +## P 列 `C3登记月` + +- 建议格式：`YYYY-MM`，且必须由 O 列日期派生。 +- 禁止与 O 列月份不一致。 + +## Q 列 `是否不良事件` + +- 枚举：`是`/`否`。 +- 与 R 列联动：若 Q=`是`，R 应为空或 `N/A`；若 Q=`否`，R 必须有原因说明。 + +## R 列 `不良事件（否）` + +- 仅在 Q=`否` 时填写，如：`未造成患者伤害`、`仅质量缺陷，无临床后果`。 +- Q=`是` 时应为空值或统一占位。 + +## S 列 `上报坏品数量` + +- 正整数，通常 1～20；特殊批量事件可更高但占比应低。 +- 与 AC（是否有样品返回）和 T/U 数量关系一致。 + +## T 列 `坏品退回QA数量` + +- 整数，范围 `0 <= T <= S`。 +- 若 AC=`否`，通常 T=0（或极低比例例外并需可解释）。 + +## U 列 `A退回原厂数量` + +- 整数，范围 `0 <= U <= T`。 +- 不应大于 T，且与处理流程状态一致。 + +## V 列 `调查报告完成日期` + +- 日期型；通常晚于 O 列。 +- 对于 `投诉状态=处理中` 可为空；`已关闭` 应有值。 + +## W 列 `调查报告（处理意见）` + +- 可用简短英文或系统化术语（如 `Replace`, `No defect found`, `Training reinforced`）。 +- 与 X 中文意见语义一致。 + +## X 列 `调查报告中文（处理意见）` + +- 中文处理意见，示例：`更换同批次产品并加强到货检验`、`复测未见异常，建议规范操作培训`。 +- 与 Y/Z/AB 结论一致。 + +## Y 列 `调查结论（处理结果）` + +- 枚举建议：`产品缺陷成立`、`操作不当`、`运输损伤`、`未复现`、`资料不足`。 +- 与故障类型、处理意见、赔付结论相互印证。 + +## Z 列 `赔付结论` + +- 枚举建议：`无赔付`、`换货`、`折让`、`退款`、`其他协商处理`。 +- 对应 Y 结果和投诉严重程度，避免明显不合理组合。 + +## AA 列 `关闭日期` + +- 日期型；`已关闭` 状态必须有关闭日期，且 `AA >= V >= O`（当 V 非空）。 +- `处理中` 可为空。 + +## AB 列 `投诉状态` + +- 枚举建议：`新建`、`调查中`、`待补充`、`已关闭`。 +- 与 V/AA 是否为空保持一致。 + +## AC 列 `有样品返回` + +- 枚举：`是`/`否`。 +- 与 T/U/S 数量字段联动（无样品返回时，通常 QA/原厂退回数量为 0）。 + +## AD 列 `事业部` + +- 事业部名称（如 `输液治疗`、`透析`、`外科`）。 +- 与 N（BU）和 G（产品名称）一致，不得错配。 + +## AE 列 `例数` + +- 整数，建议多数为 `1`，聚集性投诉可 >1。 +- 与 S 列数量逻辑可区分：`例数`是案例数，`上报坏品数量`是坏品件数。 + +# 3. 真实感与跨列关联（核心，与第 2 节配合） + +- 产品与组织一致性：`产品名称-型号-事业部-BU` 必须同一业务语境。 +- 时间一致性：`登记日期 -> 调查完成日期 -> 关闭日期` 顺序正确。 +- 状态一致性：`投诉状态` 与 `调查完成/关闭日期` 及 `处理意见`匹配。 +- 数量一致性：满足 `0 <= U <= T <= S`，并与 `有样品返回` 联动。 +- 事件一致性：`是否不良事件` 与 `不良事件（否）` 互斥逻辑严格执行。 +- 文本一致性：`故障类型`、`投诉详情`、`调查结论`、`赔付结论` 语义闭环，不互相矛盾。 + +# 4. 输出 + +新建 Excel 文件，保存到 `贝朗数据` 文件夹下。 +建议文件名：`质量投诉数据-模拟1000条-YYYYMMDD.xlsx`（日期为生成当日）。 +工作表名仍为 `complaint form`；第 1 行为原表头，第 2–1001 行为数据。 +列顺序与列名与源表头文件完全一致，便于后续 Power BI 或透视分析使用。 + +# 5. 交付时请用文字简要说明 + +- 产品清单、故障类型、事业部/BU 的生成口径。 +- 状态流转与日期逻辑（新建/调查中/已关闭）的规则。 +- 数量字段（S/T/U/AE）的约束规则与异常处理口径。 +- 明确声明：本文件为合成数据，不代表真实质量投诉或不良事件记录。 + +--- + +## 附：执行自检清单 + +| 检查项 | 合格标准 | +|------|------| +| 行数 | 总行数 1001（含表头），数据行 1000。 | +| 列结构 | 31 列列名与顺序与 `质量投诉数据-表头.xlsx` 完全一致。 | +| 编码唯一性 | A 列 `C3编号` 唯一；医院/产品关键映射稳定。 | +| 数量约束 | 全量满足 `0 <= U <= T <= S`。 | +| 日期约束 | 已关闭记录满足 `AA >= V >= O`（当 V 非空）。 | +| 状态约束 | `已关闭` 记录有关闭日期；`调查中` 可无关闭日期。 | +| 事件约束 | Q/R 列互斥逻辑一致，无冲突值。 | diff --git a/数据准备过程/表头-用户提供/不良事件数据-表头.xlsx b/数据准备过程/表头-用户提供/不良事件数据-表头.xlsx new file mode 100644 index 0000000..33af575 Binary files /dev/null and b/数据准备过程/表头-用户提供/不良事件数据-表头.xlsx differ diff --git a/数据准备过程/表头-用户提供/入院量-表头.xlsx b/数据准备过程/表头-用户提供/入院量-表头.xlsx new file mode 100644 index 0000000..368103c Binary files /dev/null and b/数据准备过程/表头-用户提供/入院量-表头.xlsx differ diff --git a/数据准备过程/表头-用户提供/药品不良事件&投诉数据-表头.xlsx b/数据准备过程/表头-用户提供/药品不良事件&投诉数据-表头.xlsx new file mode 100644 index 0000000..6be1a71 Binary files /dev/null and b/数据准备过程/表头-用户提供/药品不良事件&投诉数据-表头.xlsx differ diff --git a/数据准备过程/表头-用户提供/质量投诉数据-表头.xlsx b/数据准备过程/表头-用户提供/质量投诉数据-表头.xlsx new file mode 100644 index 0000000..21eb17a Binary files 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