BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3850199 · Received June 5, 2014

    Report

    Report Number
    1525712-2014-02881
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CONTROLLER FAULT INTERMITTENT, FUNCTION NOT THE GTRAC MODULE AS PER DEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329960 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQSPBASE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other