BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3112737 · Received May 14, 2013

    Report

    Report Number
    3004493922-2013-01053
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES GEARBOX SEEMS TO BE STRIPPED. WILL NOT DISENGAGE FROM FREEWHEEL. DOES NOT LOCK AND CHAIR CAN STILL BE PUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213106 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other