BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M300

    MDR report key: 6882271 · Received September 21, 2017

    Report

    Report Number
    1221084-2017-00083
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 21, 2017
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    END-USER REPORTED HAVING BEEN INSIDE THEIR VEHICLE HAVING JUST RETURNED HOME FROM BEING OUT. WHEN ATTEMPTING TO POWER THE DEVICE UP TO EXIT THE VEHICLE, THE DEVICE WOULD NOT TURN ON DUE TO NO POWER. END-USER REPORTED HAVING THEIR CAREGIVER PLACE THE DEVICE IN MANUAL MODE AND PUSH THE DEVICE, WITH END-USER REMAINING IN THE SEATING, INTO THEIR HOME. DURING THE TRANSITION INSIDE THE HOME, THE CAREGIVER INADVERTENTLY MANEUVERED THE DEVICE IN SUCH A MANNER THAT THE END-USERS FOOT STRUCK A PIECE OF FURNITURE CAUSING INJURY. END-USER WAS ADMITTED INTO THE LOCAL EMERGENCY ROOM WHERE THEY REPORTED TO HAVE BEEN DIAGNOSED WITH TORN LIGAMENTS AND TENDONS IN THEIR FOOT. END-USER WAS RELEASED THE SAME DAY AND IS AT HOME RECUPERATING FROM THE INJURY. VISUAL INSPECTION OF THE DEVICE SHOWN THE MAIN FUSE (CIRCUIT BREAKER) TO HAVE BEEN TRIPPED TO THE OFF POSITION. WITH THIS BEING IN THE OFF POSITION, IT WOULD NOT ALLOW THE DEVICE TO POWER UP FOR MOBILITY. ONCE THE MAIN FUSE WAS PLACED TO THE ON POSITION, POWER WAS RESTORED AND THE DEVICE OPERATED NORMALLY WITH NO ISSUES BEING NOTED. SERVICE PROVIDER INSPECTED THE DEVICE WHILE PERFORMING SERVICE FOR A NON-RELATED ISSUE. IT IS BELIEVED THAT THE REAR SHROUD COVER OF THE DEVICE, THAT COVERS THE MAIN FUSE, SHIFTED DURING TRANSPORT IN THE MOTOR VEHICLE AND HIT THE SWITCH LEVER OF THE MAIN FUSE CAUSING IT TO BE PLACED IN THE OFF POSITION. REPORTS ARE THE REAR COVER HAS BEEN REPOSITIONED AND DEVICE MANIPULATED WITHOUT RECURRENCE. THE DHR WAS REVIEWED AND UNIT MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    END-USER REPORTS HAVING LOST POWER TO THEIR DEVICE WHICH REQUIRED THE DEVICE TO BE MANEUVERED MANUALLY BY A CAREGIVER. IN THE PROCESS OF MANEUVERING THE DEVICE THOUGH THE HOME, WITH END-USER IN THE DEVICE, THE CAREGIVER INADVERTENTLY PUSHED THE CLIENT INTO A PIECE OF FURNITURE WHICH CAUSED INJURY TO THE END-USER'S FOOT REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662854 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization