BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2466639 · Received February 24, 2012

    Report

    Report Number
    1525712-2012-00295
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Report Date
    March 19, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQSP, (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151 REV I (MAY-11) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    INITIAL PR #21102 ISSUED MFG REPORT #1525712-2012-00295. THE COMPONENTS, MOTOR MODEL #1165863, SERIAL # (B)(4) AND GEARBOX, MODEL #1163413, SERIAL # (B)(4) WERE RETURNED FOR AN EVALUATION. THE MOTOR WAS VERIFIED AS LEAKING GREASE. THE RISK ASSOCIATED WITH FAILURES OF THIS TYPE WAS EVALUATED UNDER RISK ANALYSIS 1. THE RISK WAS DETERMINED TO BE AT AN ACCEPTABLE LEVEL. THIS INCIDENT DOES NOT IMPACT THAT ASSESSMENT. THIS MALFUNCTION IS CONSIDERED A RELIABILITY ISSUE THAT IS NOT LIKELY TO CAUSE HARM TO THE USER AND HAS BEEN ADDRESSED BY ENGINEERING. QUALITY REPORTS FOR CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE AND ARE EFFECTIVE IN ELIMINATING THE LEAKING GREASE CONDITION. DEVICE COMPLAINT HISTORY WAS REVIEWED. NO SERIOUS INJURY COMPLAINTS FROM LEAKING GREASE. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3GTQSP, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143151 REV I (MAY-11) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    DEALER STATED THE MOTOR ALLEGEDLY HAS A GRINDING NOISE. MOTOR ALLEGEDLY SMOKED DUE TO GREASE LEAKING FROM GEARBOX INTO THE MOTOR. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER STATED THE MOTOR ALLEGEDLY HAS A GRINDING NOISE. MOTOR ALLEGEDLY SMOKED DUE TO GREASE LEAKING FROM GEARBOX INTO THE MOTOR. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other