IEEE Access, Vol. 6, PP. 5805-5811, DOI: 10.1109/ACCESS.2017.2782088

Malfunctions of Medical Devices Due to Electrostatic Occurrences Big Data Analysis of 10 Years of the FDA's Reports


Mehdi Kohani1and Michael Pecht1, Fellow, IEEE
1CALCE, Center for Advanced Life Cycle Engineering, Department of Mechanical Engineering, University of Maryland, College Park, Maryland 20740, USA

Abstract:

An electrostatic discharge (ESD) event can cause a medical device to fail and pose a threat to patients’safety. This paper presents the data mining analysis of ESD failures in medical devices, over the last ten years, using the U.S. FDA’s manufacturer and user facility device experience database. The most frequent failure modes and activities resulting in ESD events were identified and correlated with key environmental factors. Recommendations are then presented to medical device manufacturers and hospitals.

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