Study on Adverse Events of Infant Incubator Products.
10.3969/j.issn.1671-7104.2021.03.022
- Author:
Hua YU
1
;
Jianbing YIN
2
;
Lan ZHANG
1
;
Wen WANG
1
Author Information
1. Center for Medical Device Adverse Events Monitoring of Zhejiang, Hangzhou, 311121.
2. Center for Medical Device Adverse Events Monitoring of Zhejiang, Hangzhou, 311121. E-mail:171519499@qq.com.
- Publication Type:Journal Article
- Keywords:
adverse events;
infant incubater;
medical device;
monitor
- MeSH:
Humans;
Incubators, Infant;
Infant
- From:
Chinese Journal of Medical Instrumentation
2021;45(3):335-339
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To investigate the risk of adverse events in the clinical use of infant incubators of three kinds of national medical devices in Zhejiang Province.
METHODS:Semi-quantitative matrix analysis was used to analyze the risk of adverse events related to incubator products in Zhejiang province from August 2018 to August 2019.
RESULTS:Through the risk analysis of 213 cases of adverse events of infant incubator product, the risk point and degree of the product in practical clinical application were evaluated.
CONCLUSIONS:Through the evaluation results of the production enterprises, medical institutions put forward relevant recommendations to reduce the risk of product use to prevent the recurrence of serious adverse events in the use of the product and spread.