BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL CHAIRMAN KOALA MINI-FLEX

    MDR report key: 2800429 · Received October 16, 2012

    Report

    Report Number
    1221084-2012-00020
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 13, 2012
    Manufacturer
    PERMOBIL, INC.
    Product Code
    INI
    PMA / PMN Number
    K942508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR INSPECTED THE WHEELCHAIR AND DISCOVERED THAT THE JOYSTICK WAS NOT CONNECTED PROPERLY AND HELD TOGETHER WITH ELECTRICAL TAKE WHICH PREVENTED THE CABLE FROM LOCKING IN PLACE. THE USER'S FATHER REGULARLY SWAPS BETWEEN LEFT AND RIGHT JOYSTICK MOUNTS AND DID NOT UNDERSTAND THE LOCKING DESIGN OF THE CABLE. THEREFORE, MFR CONCLUDED THAT THE FATHER REGULARLY UNPLUGS THE JOYSTICK CABLE TO CHANGE THE MOUNTING SIDE OF THE JOYSTICK AND DOES NOT PROPERLY LOCK THE CABLE TO THE JOYSTICK. WHEN THE CABLE BECOMES DISCONNECTED FROM THE JOYSTICK, THE CHAIR WILL STOP BECAUSE THERE IS NO POWER TO THE DRIVE CONTROLS. IN ADDITION, THE USER WAS NOT WEARING A POSITIONING BELT WHICH WOULD HAVE SECURED HER IN THE WHEELCHAIR WHEN IT STOPPED.

    Description of Event or Problem · 1

    USER'S FATHER REPORTED THAT THE JOYSTICK CABLE WAS LOOSE AND THE CHAIR STOPPED SUDDENLY AND THE USER FELL FROM THE WHEELCHAIR. THE USER SUFFERED A BROKEN RIGHT LEG. THE MFR INSPECTED THE WHEELCHAIR AND FOUND THAT THE JOYSTICK WAS NOT PROPERLY CONNECTED AND HELD TOGETHER WITH ELECTRICAL TAPE, WHICH PREVENTED THE CABLE FROM LOCKING IN PLACE. THE USER'S FATHER REGULARLY SWAPS BETWEEN THE LEFT AND RIGHT JOYSTICK MOUNTS AND DID NOT UNDERSTAND THE LOCKING DESIGN OF THE CABLE. THEREFORE, MFR CONCLUDED THAT THE FATHER REGULARLY UNPLUGS THE JOYSTICK CABLE TO CHANGE THE MOUNTING SIDE OF THE JOYSTICK AND HAS NEVER PROPERLY LOCKED THE CABLE TO THE JOYSTICK. WHEN THE CABLE BECOMES DISCONNECTED FROM THE JOYSTICK, THE CHAIR WILL STOP BECAUSE THERE IS NO POWER TO THE DRIVE CONTROLS. IN ADDITION, THE CLIENT WAS NOT WEARING A POSITIONING BELT WHICH WOULD HAVE SECURED HER IN THE WHEELCHAIR WHEN IT STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMOBIL CHAIRMAN KOALA MINI-FLEX POWER WHEELCHAIR INI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization