BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2940369 · Received February 2, 2013

    Report

    Report Number
    1525712-2013-00776
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT THE FORWARD AND REVERSE COMMANDS ARE BACKWARDS. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45604 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other