Abstract：Objective To investigate the feasibility of analyzing the latent design flaws of medical
equipment with the uses of the medical equipment fault report. Methods An analysis of the relevant
medical equipment maintenance data was conducted to identify devices with a high no fault found (NFF)
reporting frequency. Subsequently, the semi-structured interview was performed in order to identify
potential defects in the design in the medical equipment with higher NFF reporting frequency. Finally, the
feasibility test was conducted in order to validate if there exist any defect in the design via testing latent
feasibility of the medical equipment with a higher frequency of NFF reporting. Results The analysis of
medical equipment maintenance data identified four devices with a high NFF reporting frequency. The
semi-structured interviews and the feasibility testing revealed that usability issues caused a significant
portion of the NFF reports. Other factors suspected to contribute to the increased NFF reporting include
accessory issues, intermittent faults, and environmental issues. Usability testing conducted on two of the
devices revealed that design faults existed in the two devices. Conclusion The latent usability related
to design faults manifest themselves as an increase in NFF reporting rate. Devices containing usabilityrelated-
design faults can be identified through an analysis of medical equipment maintenance data.
王群峰. 基于医疗设备故障报告的医疗设备潜在
设计缺陷研究[J]. 中国医疗设备, 2016, 31(2): 60-62.
WANG Qun-feng. A Research on the Identification of Latent Design Flaws Based on the
Medical Equipment Fault Report. China Medical Devices, 2016, 31(2): 60-62.
