The Cause and Analysis Method of Suspected Medical Device Adverse Events

Abstract

Abstract: To draw on the human-computer engineering research Results, sum up and conclude the theoretic classification of damage and the current vast majority causes of suspected medical device adverse incidents, compare the current widespread using of security incidents analysis Methods in the feasibility analysis, we found the analysis modeled from the fault tree is relatively reliable and generally applicable to cause analysis of suspi-cious incident.

Key words: suspected medical device adverse event, damage, cause analysis, method, fault tree

CLC Number:

JIANG Dong-gui, WANG Gang, NUERJIANG·shabukai, LI Lei. The Cause and Analysis Method of Suspected Medical Device Adverse Events[J]. Chinese Journal of Pharmacovigilance, 2010, 7(1): 7-11.

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