BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3233362 · Received July 18, 2013

    Report

    Report Number
    1525712-2013-05890
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 27, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES STOP BOLT FOR BRAKE LEVER BROKE OFF MOTOR CAP, CAUSING INTERMITTENT BRAKE FAULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334934 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX-3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other