Detecting software failures in the MAUDE database: a preliminary analysis.
The MAUDE (Manufacturer and User facility Device Experience) was analyzed to identify challenges in detecting software failure causing Medical Device (MD) adverse events.
National Research Council, Institute for Research on Population and Social Policies, Rome, Italy.
Fabrizio
F
Pecoraro
Daniela
D
Luzi
D057225:Data Mining / Q000379:methods*; D016208:Databases, Factual; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis / Q000379:methods / Q000706:statistics & numerical data; D004869:Equipment Safety / Q000706:statistics & numerical data*; D019221:Mandatory Reporting; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data; D012308:Risk Management / Q000379:methods; D012984:Software / Q000706:statistics & numerical data*; D012985:Software Design; D012986:Software Validation; D014481:United States; D014486:United States Food and Drug Administration