Abstract：Objective To quantitatively evaluate the potential risks of infant incubator in use. Methods
The breakdown maintenance records and department management data of infant incubators in department
of pediatrics in our hospital before 2014 were collected, systemized and summarized. The failure modes
and effects analysis (FMEA) was used to identify the failure mode. Then, according to evaluation
standards of severity (S), occurrence (O) and detection (D), the risk priority number (RPN, RPN=S x
O x D) was calculated. Afterwards, the risk control measure was proposed and implemented to analyze
whether RPN value was reduced or not. Results The average RPN value of 9 main failure modes
identified in infant incubators was 29, subsequently was reduced to 7 in one year after implementing risk
control measures of FMEA. Conclusion The FMEA could be applied to obviously reduce clinical use
risks of infant incubators as well as the occurrence of potential failure modes.
周兴朝a，杨淑娟b，马妮b，段文清a，周和良a. 基于失效模式与效应分析婴儿培养箱风险分析[J]. 中国医疗设备, 2017, 32(3): 143-145.
ZHOU Xing-chaoa,YANG Shu-juanb, MA Nib,DUAN Wen-qinga,ZHOU He-lianga. Risk Analysis of Infant Incubator Based on Failure Modes and Effect Analysis. China Medical Devices, 2017, 32(3): 143-145.
