BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3022196 · Received March 26, 2013

    Report

    Report Number
    1525712-2013-02328
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER, THE CHAIR IS MALFUNCTIONING. ONCE IT IS ON IT DOESN'T TURN OFF WITH OUT UNPLUGGING THE JOYSTICK. VICE VERSA WHEN THE CHAIR IS OFF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123743 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91

    Patients

    Seq Age Sex Outcome Treatment
    1 Other