BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2991879 · Received March 6, 2013

    Report

    Report Number
    3004493922-2013-00538
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES QUICK RELEASE PIN TO ATTACH TO THE ONE PIECE FOOTBOARD IS BROKEN, IT CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95438 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other