BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2031707 · Received March 22, 2011

    Report

    Report Number
    1525712-2011-00122
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY IS REPORTED. THE DEALER HAS THE USER CHAIR FOR SERVICE AND STATES HE OBSERVED SMOKE COMING FROM THE CONTROLLER AND OBSERVED SOME MELTING. CHAIR IS 5 YEARS OLD AND NO LONGER IN WARRANTY. ELECTRONIC MALFUNCTIONS WITHIN THE CONTROLLER, INCLUDING ANY DEBRIS THAT MAY RESULT, ARE WELL CONTAINED WITHIN THE METAL ENCLOSURE OF THE DEVICE. NO RISK OF SHOCK IS PRESENTED TO THE USER. AS IN MANY ELECTRONIC COMPONENT FAILURES, SOME DEGREE OF SMOKING LIKELY OCCURRED; HOWEVER, THIS IS NOT AN INDICATION OF SUSTAINED COMBUSTION. MALFUNCTION HAS NOT BEEN ESTABLISHED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE JOYSTICK WAS ALLEGEDLY SMOKING AND THE BATTERY CABLE COMING FROM THE CONTROLLER WAS MELTED. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDX3-PS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR