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Track 1 Session 6
10:30 to 11:30 a.m. Thursday March 27, 2008
Reliability Predictions for Complex
Medical Devices: Field Return and Warranty Forecasts
This presentation will describe the
Trixell experience with field returns and warranty cost forecasts.
For fielded products, a Weibull analysis approach, based on Maximum
Likelihood Estimation, is widely used to build reliability roadmaps.
Life data analysis on repairable systems is performed on data from a
well-filled after-sale-service database (FRACAS – Failure Reporting,
Analysis and Corrective Action System). Studies per failure mode
allow us to estimate global failure probability during the warranty
period. In product life cycle management, the impact on product
reliability of major future modifications can also be evaluated by
combining Weibull results and discussions with designers.
Afterwards, a global Weibull model is deduced for each delivery
period and, using the complete field installed base, warranty
forecasts are predicted. This presentation will discuss the process
and tools used to calculate these estimations, as well as lessons
learned.
Key Words: Field Life Data Analysis, Warranty Forecast,
Weibull, MLE, Repairable Systems
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