BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M300

    MDR report key: 3971823 · Received July 31, 2014

    Report

    Report Number
    1221084-2014-00021
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 31, 2014
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K103477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLIENT IS USING A PIECE OF PVS PLUMBING PIPE AS A JOYSTICK HANDLE. THIS IS VERY HEAVY AND IS CAUSING THE JOYSTICK TO NOT BE ABLE TO RETURN TO NEUTRAL. ONCE THE WEIGHT OF THE PVC WAS FORWARD, THE CLIENT DID NOT HAVE EITHER THE STRENGTH OR REFLEXES TO STOP HER MOTION.

    Description of Event or Problem · 1

    CLIENT HAD JUST FINISHED HER APPOINTMENT AND WAS BEING HELPED TO THE PARKING LOT TO CATCH HER RIDE. THE HELPER SAID SHE PRESSED THE WALL PLATE FOR THE AUTOMATIC DOOR AND HELD IT SO IT WOULDN'T CLOSE ON CLIENT. SHE SAID THE CLIENT WENT THROUGH THE DOOR AND WAS CLOSE TO THE LEFT SIDE. AFTER SHE CLEARED THE DOOR THE CHAIR CONTINUED TO GO STRAIGHT AND SHE YELLED TO "STOP" OR "TURN". SHE SAID IT HAPPENED IN A SPLIT SECOND, SHE COULDN'T EVEN GRAB THE CHAIR IN TIME. THE CLIENT AND THE CHAIR WENT DOWN THE 1 AND 1/2 STEPS. THE CHAIR TIPPED FORWARD AND LANDED ON THE CLIENT AS SHE WAS WEARING HER SEAT BELT. THEY CALLED 911 AND EMS TRANSPORTED HER TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446655 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other