BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2000598 · Received February 2, 2011

    Report

    Report Number
    1525712-2011-00037
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ALLEGES WHEN THEY PLUGGED A JOYSTICK IN IT SPARKED, AND THEY SMELLED SMOKE. IT'S UNK WHY THE DEVICE WAS UNPLUGGED FROM THE CHAIR. DEVICE HAS BEEN IN USE FOR 6 MONTHS. FILING ON THE USER'S ALLEGATION OF A SPARK, AND SMOKE SMELL ON WHAT APPEARS TO BE THE RESULT OF SERVICING THE CHAIR. MALFUNCTION IS NOT CONFIRMED. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE OR A SERVICE ERROR THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS ALLEGED INCIDENT. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER STATES WHEN HE PLUGGED IN THE JOYSTICK, IT ALLEGEDLY SPARKED AND HE SMELLED SMOKE. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDXSPREE-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR