目的 通过医疗器械不良事件报表质量评估工作，发现医疗器械不良事件上报过程中存在的问题。方法 采用非概率抽 样与概率抽样相结合的方法，典型调查死亡报告，重点调查严重报告，分层抽样一般报告。结果 北京市2016年第三季度共 收到报表1571份，抽取样本比例为10%，共抽取160份，不重复分层抽样平均误差为μ=0.0229。结论 本研究提出了逐步提高 报表填报质量的措施，为医疗器械不良事件报表的分析和评价提供有效数据和基础，使医疗器械的风险控制更加科学。

Objective To investigate the problems of the medical device adverse event reports through the reports’ quality evaluation. Methods The non probabilistic sampling and probability sampling were used to investigate the reports according to the injure severity. The typical investigation of the death reports, the major investigation of the serious injury reports, and the stratified sampling of the general reports were used in this progress. Results A total of 1571 medical device adverse event repots were received in the third quarter 2016, the sample proportion was 10%, the number of the sampling was 160, and the stratified sampling average error was 0.0229. Conclusion Some measures were put forward to improve the reporting quality gradually in this paper, which would provide effective data and foundation for analysis and evaluation of adverse event reports of medical devices, and make the risk control of medical devices more scientific.