Objective:To analyze medical device adverse events, strengthen their supervision and improve the quality and safety of medical treatment. Methods:The adverse events were analyzed in five cases of syringe driver, hemodialysis machine, infusion pumps, surgical suture and PICC. Results:The factors which lead to five cases of medical device adverse events are mainly embodied in the product quality problems, the misoperation and medical staff treatment and care improper. Conclusion:Medical institutions should strengthen the publicity and education of medical device adverse events, encourage to report medical device adverse events, make periodic summary analysis, prevent the occurrence of similar incidents, and improve medical quality and safety.%目的：对医疗器械不良事件案例进行分析，提出加强医疗器械不良事件监管的措施，保障使用安全，提高医院医疗质量。方法：对注射泵、血液透析机、输液泵、医用缝合线以及中心静脉导管发生的5例不良事件案例，分别进行分析，找出不良事件发生原因。结果：导致5例医疗器械不良事件的原因主要为产品质量问题、使用操作不规范以及医务人员施治与监测不当等。结论：医疗机构应加强医疗器械不良事件的宣教工作，建立医疗器械不良事件的上报机制，定期汇总分析，杜绝类似事件发生。
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