BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1982136 · Received January 14, 2011

    Report

    Report Number
    1525712-2011-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    August 17, 2010
    Report Date
    January 13, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER WAS SERVICING THEIR CHAIR WHEN THEY HEARD A POP AND OBSERVED A PUFF OF SMOKE EMIT FROM THE JOYSTICK. THE JOYSTICK WAS RECEIVED AND INSPECTED. NO EXTERNAL DAMAGE WAS OBSERVED. THE JOYSTICK WAS CONNECTED TO A WHEELCHAIR POWERED ON AND OPERATED WITH NO DISCREPANCIES. INTERNAL INSPECTION OF THE JOYSTICK REVEALED A DAMAGED CAPACITOR. ALL DAMAGE TO THE COMPONENT WAS CONTAINED WITHIN THE METAL ENCLOSURE OF THE JOYSTICK. NO RISK OF SHOCK IS PRESENTED TO THE USER. AS IN ANY ELECTRONIC COMPONENT FAILURE, SOME DEGREE OF SMOKING CAN OCCUR; HOWEVER, THIS IS NOT AN INDICATION OF SUSTAINED COMBUSTION. THE DEVICE HAS BEEN REPLACED AND THE CHAIR REMAINS IN USE.

    Description of Event or Problem · 1

    AFTER INSTALLING A NEW JOYSTICK ON THE CHAIR, THE DEALER ALLEGEDLY SAW A PUFF OF SMOKE COME OUT OF THE CHARGER PORT. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE MK6-MPJC

    Patients

    Seq Age Sex Outcome Treatment
    1