BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M3 CORPUS

    MDR report key: 23104094 · Received September 20, 2025

    Report

    Report Number
    1221084-2025-00013
    Event Type
    Injury
    Date Received
    September 20, 2025
    Date of Event
    July 6, 2025
    Report Date
    September 20, 2025
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL REPRESENTATIVE RECEIVED NOTICE FROM THE PROVIDER OF AN INCIDENT HAVING OCCURRED WHERE IT WAS CLAIMED WHILE THE END-USER WAS TRAVERSING THROUGH THEIR HOME IN THE M3 CORPUS, THE DEVICE REPORTEDLY LOST POWER WHICH CAUSED THE DEVICE TO STOP FORWARD MOMENTUM. THIS ACTION REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO THE FLOOR WHERE THE SUSTAINED A FRACTURED HIP. PERMOBIL REPRESENTATIVE WAS ASKED TO INSPECT THE DEVICE WHERE THE DEVICE WAS FOUND TO REMAIN FULLY OPERATIONAL WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. DURING INSPECTION WITH THE DEALER, PERMOBIL WAS INFORMED THAT THE DEALER HAD INSPECTED THE DEVICE PRIOR TO PERMOBIL'S ARRIVAL, AND THEY ALSO WERE UNABLE TO REPRODUCE THE REPORTED LOSS OF POWER, BUT THEY REPLACED THE BATTERIES AFTER REVIEW OF THE SYSTEM LOGS INDICATED MULTIPLE LOW BATTERY MESSAGES HAVING BEEN LOGGED. AS THE DEVICE WAS FOUND TO REMAIN FULLY OPERATIONAL, AND THE SERVICE PROVIDER HAVING REPLACED COMPONENTS PRIOR TO EVALUATION, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO PROBABLE ROOT CAUSE WITHOUT SPECULATION. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED REPORT INDICATING AS THE END-USER WAS DRIVING THEIR PERMOBIL M3 CORPUS INSIDE THEIR HOME, THE DEVICE ALLEGEDLY LOST POWER. THIS ACTION REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING WHERE THEY SUBSEQUENTLY FELL OUT OF THE SEATING TO THE FLOOR WHERE THEY WERE REPORTED TO HAVE SUSTAINED A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808404 PERMOBIL M3 CORPUS POWERED WHEELCHAIR ITI PERMOBIL INC. M3 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization