BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL M300 CORPUS 3G

    MDR report key: 3040591 · Received March 12, 2013

    Report

    Report Number
    1221084-2013-00006
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 12, 2013
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    PMA / PMN Number
    K103477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEELCHAIR WAS INSPECTED BY MFR AT THE USER'S HOME. BASED ON A VISUAL INSPECTION, THE WIRES ATTACHED TO THE SWITCHBOX WAS DAMAGED AFTER THE CLIENT RAN INTO SOMETHING. THE DAMAGE TO THE WIRES CAUSED THE WIRES TO SHORT CIRCUIT. THE SWITCHBOX HAS BEEN REMOVED AND THE CLIENT IS COMFORTABLE OPERATING THE SEATING FUNCTIONS THROUGH THE JOYSTICK.

    Description of Event or Problem · 1

    THE SWITCHBOX WAS MOUNTED AT THE END OF THE ARMREST OPPOSITE THE JOYSTICK ON THE POWER WHEELCHAIR. THE MOUNTING BRACKET HAD BROKEN LIKELY AS A RESULT OF THE USER RUNNING INTO SOMETHING, WHICH CAUSED STRESS AT THE POINT WHERE THE WIRE EXITS THE SWITCHBOX. THE WIRE HAD A SHORT CIRCUIT AND CAUSED SOME SMOKE. THE INSULATION OF THE WIRES IS SELF EXTINGUISHING. THE USER DID NOT REPORT ANY INJURY. THE SWITCHBOX WAS REMOVED FROM THE WHEELCHAIR AND THE WHEELCHAIR FUNCTIONS PROPERLY WITHOUT THE SWITCHBOX ATTACHED. THE USER IS COMFORTABLE OPERATING THE SEAT FUNCTIONS THROUGH THE JOYSTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104493 PERMOBIL M300 CORPUS 3G POWER WHEELCHAIR ITI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1