BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4220207 · Received November 3, 2014

    Report

    Report Number
    1525712-2014-07535
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    July 9, 2014
    Report Date
    October 14, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ENDUSER ADVISED THE RIGHT MOTOR ASSEMBLY IS NOT WORKING PROPERLY. ENDUSER ADVISED RIGHT WHEEL WILL NOT MOVE. ENDUSER ADVISED CONTACTED XMED (B)(6) 2014 AND STILL HAVE NOT RECEIVED PARTS. ENDUSER ADVISED NOW JOYSTICK IS FLASHING A WRENCH AND CHAIR WILL NOT WORK. ENDUSER ADVISED LEFT ARM PAD IS TORN, CASTERS ARE KNICKED UP, DRIVE WHEELS ARE WORN, AND A PIECE IS BROKEN OFF THE FOOTBOARD CAUSING IT TO FLOP DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701202 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M61

    Patients

    Seq Age Sex Outcome Treatment
    1 Other