Sahni, Ashweni K.; Myrum, Stanton D. (1987, ASQC) Medtronic, Inc., Minneapolis, MN
Over the last ten years, Fault Tree Analysis has been frequently utilized in a wide vareity of industries, particularly where the products manufactured are required to have high reliability. Medtronic, Inc. Manufactures implantable cardiovascular devices (e.g., implantable pacemakers and their leads) of high quality and reliability. Therefore, it was felt appropriate to try this techniique for a product in its development stage.The objective of this paper is to demonstrate the application of Fault Tree Analysis for an implantable pacemaker lead which has a unipolar design and has silicone insulation. The approach used was the bakcward analysis technique. The top event (Failure/Hazard) was defined first and then a causal relationship was established for the subsequent events that might lead to the top event. At appropriate points the analysis was terminated when it was unnecessary to analyze those events in more detail.