Objective: International Medical Device Regulators Forum (IMDRF) has updated version 5.0 of Terminologies for categorized Adverse Event Reporting (AER): terms, terminology and codes. The purpose of this study is to analyze the feasibility and necessity of the cause investigation terms (Annex B, C, D) applied to the investigation, analysis and evaluation of adverse events of active medical devices. Methods: Using the terms to sort out the investigation type of adverse events of medical devices, the investigation results of 447 reports of adverse events of medical devices causing serious damage were statistically analyzed, and the investigation conclusions of the events were summarized. Results: The investigation types mainly include product testing, interview and production record analysis. The top three active medical devices with serious adverse events were patient monitor, electronic needle therapy instrument and traditional Chinese medicine fumigation machine. The main investigation results of adverse events were mechanical problems dominated by wear, electronic component problems and degradation problems. The main causes traced to common component failures, incorrect maintenance and user problems.Conclusion: IMDRF cause investigation terms has certain reference significance for the monitoring of adverse events of active medical devices in China, and provides technical reference for the relevant units to carry out the investigation, evaluation, supervision and inspection of adverse events reports of active medical devices. 

本文由广州佳誉医疗器械有限公司/佛山浩扬医疗器械有限公司联合编辑