BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3003078 · Received March 13, 2013

    Report

    Report Number
    3004493922-2013-00590
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER SAYS THE CHAIRS RIGHT MOTOR LOCKS UP. THE DEALER ALSO STATES THAT THE FACILITY SAYS SOMETHING SMELLS LIKE ELECTRICAL BURNING. THE DEALER HAS NOT SMELLED ANYTHING BURNING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106021 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51SEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other