BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4133108 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06587
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTABLE MALFUNCTION FOR THIS DEVICE; PER DEALER, LIGHTS ARE NOT WORKING, STATED ONE LIGHT STARTED SMOKING BEFORE THEY STOPPED WORKING. ADDITIONAL NON-REPORTABLE COMPLAINT FOR THIS DEVICE; THE LEFT MOTOR IS SQUEALING

    Description of Event or Problem · 1

    PER DEALER, LIGHTS ARE NOT WORKING, ONE LIGHT STARTED SMOKING BEFORE THEY STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610900 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other