BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C400 CORPUS

    MDR report key: 3070243 · Received April 1, 2013

    Report

    Report Number
    1221084-2013-00008
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 29, 2013
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MANUFACTURER INSPECTED THE WHEELCHAIR AND THE JOYSTICK. THE BOOT WAS TORN OFF OF THE JOYSTICK AND A SIGNIFICANT AMOUNT OF DIRT AND DEBRIS WAS IN THE JOYSTICK. BOTH THE MANUFACTURER AND DEALER DETERMINED THAT THE JOYSTICK MALFUNCTION WAS CAUSED BY THE DIRT AND DEBRIS IN THE JOYSTICK.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT THAT THE CLIENT STATED THAT THE JOYSTICK STUCK AND AS A RESULT WAS UNABLE TO STOP THE WHEELCHAIR AND DROVE THROUGH A PLATE GLASS WINDOW. ALTHOUGH DEALER FIRST REPORTED THAT CLIENT WAS INJURED, NEITHER DEALER NOR CLIENT WOULD CONFIRM ANY INJURIES. MANUFACTURER INSPECTED THE JOYSTICK AND A SIGNIFICANT AMOUNT OF DIRT AND DEBRIS WAS IN THE JOYSTICK. BOTH THE MANUFACTURER AND DEALER DETERMINED THAT THE JOYSTICK MALFUNCTION WAS CAUSED BY THE DIRT AND DEBRIS IN THE JOYSTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131414 PERMOBIL C400 CORPUS POWER WHEELCHAIR ITI PERMOBIL AB

    Patients

    Seq Age Sex Outcome Treatment
    1