Analysis of ventilator fatal adverse events in FDA MAUDE database
10.19745/j.1003-8868.2023213
- VernacularTitle:美国FDA MAUDE数据库呼吸机致死不良事件分析
- Author:
Zhi-Jie FANG
1
;
Gang CHEN
;
Wen-Guang ZHOU
Author Information
1. 陆军第七十三集团军医院,福建厦门 361001
- Keywords:
the U.S.FDA MAUDE database;
ventilator;
adverse events;
lethal factor
- From:
Chinese Medical Equipment Journal
2023;44(10):86-90
- CountryChina
- Language:Chinese
-
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]
