BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL M300

    MDR report key: 7927392 · Received October 2, 2018

    Report

    Report Number
    1221084-2018-00058
    Event Type
    Death
    Date Received
    October 2, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 30, 2018
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO MANUFACTURER FOR EVALUATION. UNIT WAS FOUND TO BE FULLY OPERATIONAL WITH NO KNOWN MALFUNCTIONS OR DEVIATIONS BEING NOTED. REVIEW OF THE PROGRAM FILE DID NOT SHOW ANY INDICATIONS OF IRREGULAR PROGRAM SETTINGS. REVIEW OF THE SYSTEM ERROR LOGS DID NOT REGISTER ANY ERRORS HAVING OCCURRED THAT WOULD CORRESPOND TO THE REPORTS OF UNINTENDED DRIVE OR ACCELERATION. DEVICE WAS TEST DRIVEN ON VARIOUS TERRAINS AND INCLINE/DECLINES. AT NO POINT DURING THE DRIVE TESTS DID THE DEVICE FAIL TO STOP AFTER RELEASE OF THE JSM INDUCTIVE, NOR ACCELERATE WITHOUT BEING GIVEN A JSM COMMAND. IT REMAINS UNCLEAR AS TO THE CIRCUMSTANCES SURROUNDING THE REPORTED EVENT. ROOT CAUSE CANNOT BE DETERMINED AS NO DEVIATIONS NOR MALFUNCTIONS WERE FOUND TO HAVE OCCURRED WITH THE DEVICE. NO CORRECTIVE ACTIONS CAN BE TAKEN AS NO FAILURE COULD BE DETERMINED. DEVICE WAS RETURNED TO THE OWNING AUTHORITY IN THE SAME CONDITION IN WHICH IT WAS PRESENTED TO THE MANUFACTURER. THE DHR WAS REVIEWED AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED REPORT OF AN INCIDENT HAVING OCCURRED WHERE THE END-USER HAD FALLEN OUT OF THEIR DEVICE AFTER IT HAD ALLEGEDLY ACCELERATED UNCONTROLLABLY. REPORTS INDICATE THE END-USER WAS NOT WEARING THE SUPPLIED POSITIONING BELT AND WHEN THE DEVICE HIT A BUMP IN THE TERRAIN, THE END-USER LOST POSITIONING AND FELL OUT OF THE SEATING TO THE GROUND. REPORTS INDICATE THE END-USER WAS TRANSPORTED TO THE HOSPITAL TO WHERE HE WAS DIAGNOSED AS SUFFERING A FRACTURED LEG, HIP, SHOULDER AND RIBS. IT WAS REPORTED THE FOLLOWING DAY AS END-USER WAS BEING DISCHARGED, COMPLICATIONS SET IN TO WHERE THE END-USER SUBSEQUENTLY DIED. THE SUSPECT DEVICE WAS RETRIEVED FROM THE END-USER'S FAMILY AND IS BEING RETURNED TO PERMOBIL FOR EVALUATION AND EXAMINATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF DEVICE EVALUATION.

    Description of Event or Problem · 1

    RECEIVED REPORT INDICATING AS END-USER WAS DRIVING THE DEVICE, THE CHAIR ALLEGEDLY ACCELERATED HEADING TOWARDS A FENCE AT THE END OF THE PROPERTY. REPORTS INDICATE BEFORE REACHING THE FENCE, THE DEVICE HIT A BUMP AND THE END-USER LOST POSITIONING AND FELL OUT OF THE SEATING TO THE GROUND TO WHERE THEY WERE PINNED BETWEEN THE DEVICE AND THE FENCE. REPORTS INDICATE THE END-USER WAS TAKEN TO A LOCAL HOSPITAL TO WHERE IT WAS REPORTED THEY SUBSEQUENTLY DECEASED DUE TO COMPLICATIONS RELATED TO THEIR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769338 PERMOBIL M300 POWERED WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H