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Lessons from 342 Medical Device Failures



D Wallace, David R. Kuhn


Today's highly complex systems often contain software. Lessons can be learned about softwaredevelopment and assurance concerning quality practices, from system failures activated bysoftware faults. This paper presents an analysis of failures of medical devices; the failurescaused no death or serious injury. The analysis categorizes the symptoms, or types offailures, and the software faults that caused the failures. The nature of the faults provideslessons about quality practices, that is, prevention and detection methods to be appliedbefore systems are released for operation.
IEEE International High Assurance Systems Engineering Symposium


high assurance, medical devices, quality practices, software faults, system failures


Wallace, D. and Kuhn, D. (1999), Lessons from 342 Medical Device Failures, IEEE International High Assurance Systems Engineering Symposium (Accessed April 20, 2024)
Created November 17, 1999, Updated February 17, 2017