Abstract:Objective：The application of FMEA（Failure Mode and Effect Analysis）management tools in the monitoring and management of medical device adverse events is discussed to optimize the reporting process of medical device adverse events，improve the number and quality of reports，and ensure the safety of clinical use. Methods：Set up the FMEA team to identify，analyze and evaluate risks in the process of monitoring and management of medical device adverse events. Identify potential failure modes，conduct critical value evaluation and hazard analysis，and formulate intervention improvement measures based on the analysis results. Results：After the implementation of the intervention measures，the detection and management of medical device adverse events have been significantly improved compared with those before the implementation. The number of reports has increased by 110.47%，and the approval rate of reports has increased by 16.87%. Conclusion：Applying FMEA tools to the monitoring and management of medical device adverse events，identifying potential failure modes in the process，and formulating targeted improvement measures can effectively improve the supervision and management quality of adverse events.