BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3200510 · Received July 1, 2013

    Report

    Report Number
    3004493922-2013-01379
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER REPORTED THE PIVOT SEAT HANDLE BROKE ON THE M51 POWERED WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298218 POWERED WHEELCHAIR 890.3860 IOR INVACARE SUZHOU M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other