Risk Analysis of Pacemaker System Based on Failure Mode and Effect Analysis

Abstract

Abstract: ObjectiveTo investigate issues of the cardiac pacemaker in use process and analyze potential risks caused by these issues, then to analyze and improve parts on highest risk value to ensure the safety and effectiveness of the cardiac pacemaker in the whole life cycle. MethodsUsing FMEA to study the potential risk of the cardiac pacemaker. ResultsThe highest risk value of cardiac pacemaker is wire. The article adopts ANSYS to simulate wire structure to explore some changes in structure features from the micro when it fractures. Then tentative improvement was carried out on the wire according to the theory of wire mechanical property. ConclusionPerformance of wire of the cardiac pacemaker is improved, service life of the cardiac pacemaker is extended.

Key words: risk management, Failure Mode and Effect Analysis, cardiac pacemaker, risk analysis

CLC Number:

R917

CHENG Yun-zhang, LUO Wen-xiang, HUANG Fang-fang. Risk Analysis of Pacemaker System Based on Failure Mode and Effect Analysis[J]. Chinese Journal of Pharmacovigilance, 2014, 11(2): 104-108.

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