Data Analysis and Research Design Study on Congestive Heart Failure
Failure and Design
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Transcript of Failure and Design
Failure and Design
Jaime BaberOctober 12, 2000BME 272: Dr. Paul H. King
Introduction Failure: Degradation of
performance of a device outside of a specified value
Non Performance or inability to perform for a certain time within space conditions
Causes of Failure: Systemic and Random
Diabetes Test Kit
Defect : An imperfection (which may/may not lead to failure)
Deficiency: Lack of conformance to specifications
Malfunction: Unsatisfactory performance
Fault: Cause of failure Could be something in
environment Something that happens to
device: not internal
Similar Terms
Failure is a fact of life...
Failure is a fact of life... Define operational
issues/normal operation Failure rate Anticipate the worst Failure Mode Analysis Design around it: FAIL SAFE
Hardware Failure
Early: First 1,000 hours Random: Mid-life Wearout: Late Artificial Hip
Software Failure
Specification errors Design Error Typo Ommission Lack of Verification
Human Error….
Human Error Most important Documentation: Not up-
to-date or missing Engineers must review
and test Track Failures
Reliability Describes how dependable a
device is over time Performs for a stated
environment/time w/o failure Plan/Design/Manufacture
reliability into product vs Quality
Mechanical Reliability Due to deterioration of design
strength or assembly
Electronic Reliability
Three distinct time periods
Software Reliability
Overall Device Reliability
Reliabilty Assurance Design Fault Tolerance Improve Manufacturing Quality Assurance Teams/
Inspect Service Manuals Test Monitor
Design….
designsafe... Task Based Safety Analysis
Hazard AnalysisUsersTasks
Risk AssessmentFour levels of severity