BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 17611919 · Received August 24, 2023

    Report

    Report Number
    3008370857-2023-00024
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    May 28, 2021
    Report Date
    August 24, 2023
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL WAS INFORMED OF AN EVENT HAVING OCCURRED APPROXIMATELY 2 YEARS PRIOR, WHERE IT WAS ALLEGED, THE USER WAS TRAVERSING UP AN INCLINED SURFACE IN A MANUAL WHEELCHAIR WHILE UNDER POWER OF A SMART DRIVE MX2+. THE DEVICE REPORTEDLY LOST POWER, STOPPING FORWARD MOTION. THIS ALLEGEDLY CAUSING THE WHEELCHAIR TO START ROLLING BACKWARDS, SPINNING AROUND, WHICH FORCED THE END-USER TO LOSE BALANCE AND FALL FROM THE SEATING WHERE THEY REPORTED TO HAVE SUSTAINED AN FX TO THEIR FEMUR. THE ALLEGATION PRESENTED IS THE BATTERY HAD RUN OUT OF POWER, AND DUE TO AN ALLEGED FLAW IN DESIGN, FAILED TO WARN THE USER OF THE NEED TO CHARGE. PERMOBIL HAS NO RECORD OF A REPORT HAVING BEEN RECEIVED IN THE TIMELINE IN WHICH THE EVENT ALLEGEDLY OCCURRED. DUE TO DURATION FROM EVENT TO AWARENESS, PERMOBIL IS UNABLE TO CONFIRM A PRODUCT FAILURE HAVING OCCURRED, THUS IS UNABLE TO REACH A DETERMINATION AS TO PROBABLE CAUSE WITHOUT SPECULATION. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING WHILE USING A SMART DRIVE MX2+ DEVICE TO PROPEL A MANUAL WHEELCHAIR UP AN INCLINED SURFACE, THE SMART DRIVE UNIT ALLEGEDLY POWERED OFF. THIS REPORTEDLY CAUSED THE WHEELCHAIR TO ROLL BACKWARDS AND TURN QUICKLY TO THE SIDE. THIS ACTION REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE WHEELCHAIR SEATING, LEADING TO AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101539 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization