医疗卫生装备2023，Vol.44Issue(10)：86-90,5.DOI:10.19745/j.1003-8868.2023213
美国FDA MAUDE数据库呼吸机致死不良事件分析
Analysis of ventilator fatal adverse events in FDA MAUDE database
方志杰 1陈岗 1周文光1
作者信息
- 1. 陆军第七十三集团军医院,福建厦门 361001
- 折叠
摘要
Abstract
The data on reported adverse events of ventilators in the U.S.Food and Drug Administration(FDA)Medical Device Manufacturer and User Facility Device Experience(MAUDE)database were searched from January 1,2022 to December 31,2022,of which the data on ventilator fatal adverse events were extracted and statistically analyzed with Python.The main causes for ventilator fatal adverse events were pointed out including degradation of noise-reducing foams,improper use and ventilator malfunction,and some suggestions were put forward accordingly from the aspects of material,manufacturer,user,maintainer and supervisor.References were provided for utilization management and adverse events control for other medical devices.[Chinese Medical Equipment Journal,2023,44(10):86-90]关键词
美国FDA MAUDE数据库/呼吸机/不良事件/致死因素Key words
the U.S.FDA MAUDE database/ventilator/adverse events/lethal factor分类
医药卫生引用本文复制引用
方志杰,陈岗,周文光..美国FDA MAUDE数据库呼吸机致死不良事件分析[J].医疗卫生装备,2023,44(10):86-90,5.
