Abstract：Objective To develop a monitoring system for the malfunction and adverse events management of in-service medical
device, improve the reporting quantity and efficiency of medical device adverse events, and assist the medical equipment supervision
department in mastering the use of medical equipment. Methods The system needed to log in through Outstanding CE app. The
system involved five modules, including equipment information management module, equipment fault maintenance module,
equipment daily inspection module, adverse event reporting module and medical equipment operation data statistics module. The
user needed to input the basic information of the equipment in the medical institution into the system first, and then, according to the
cycle of daily inspection work, filled in the system with the inspection results of the equipment and the real information of the faults
and adverse events regularly. Finally, the data could be exported through the data statistics module. Results Through this system,
users could view all the equipment information of the medical institution at anytime and anywhere, including the working status,
maintenance records, inspection records, so as to facilitate the management of the medical equipment in use of the medical institution
by the person who was in charge. Conclusion This system is easy to use and simple to operate. It solves the problems of the
original paper record method, such as time-consuming, inconvenient storage and unable to view in real time. At the same time, the
stakeholders of medical device, including equipment managers, equipment users, benefited patients and their families, can participate
in the reporting of medical device adverse events by using this system.
赵观宇. 在用医疗设备故障及不良事件监管系统的研究与应用[J]. 中国医疗设备, 2021, 36(1): 119-122.
ZHAO Guanyu. Research and Application of Medical Device Malfunction and Adverse Event Monitoring System. China Medical Devices, 2021, 36(1): 119-122.
