BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2549639 · Received April 26, 2012

    Report

    Report Number
    3004493922-2012-00106
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 25, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRR, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 6 MONTHS OLD. THE USER MANUAL PART NUMBER 1143206 REV G (FEB-09) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A (B)(6) FEMALE. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRR, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 6 MONTHS OLD. THE USER MANUAL PART NUMBER 1143206 REV G (FEB-09) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A (B)(6). THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. (B)(4) ISSUED MFG REPORT #3004493922-2012-00106 WITH INVACARE (B)(4) AS THE MANUFACTURER. THE CORRECT MANUFACTURER IS INVACARE (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGES RIGHT MOTOR GEARBOX IS LOCKING UP AND BOTH RIGHT AND LEFT MOTOR GEARBOXES HAVE A VERY LOUD GRINDING NOISE. (B)(4). NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES RIGHT MOTOR GEARBOX IS LOCKING UP AND BOTH RIGHT AND LEFT MOTOR GEARBOXES HAVE A VERY LOUD GRINDING NOISE. (B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 DA Other