Examining Root Causes of Medical Device Alarm System Failures Using Reports From Food and Drug Administration’s Medical Product Safety Network (MedSun)

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Abstract

This article analyzes medical device reports related to medical device alarm system performance issues by categorizing the underlying failure causes and examining alarm system misses and false alarms. When a miss or false alarm occurs, the typical causes of the failure were either device or operator related. The most typical device-related failure was an unexpected component failure, whereas the typical operator-related failure resulted from a human factor performance issue with the device. These results suggest that, by improving the quality and usability of medical devices, the number of problematic false alarms and misses may be reduced.

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