BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 24548097 · Received March 9, 2026

    Report

    Report Number
    3008370857-2026-00329
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 9, 2026
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT CLAIMED WHEN THE END-USER PRESSED THE SWITCH CONTROL TO STOP THE MX2+ SMARTDRIVE UNIT, THE DEVICE FAILED TO DISENGAGE THE DRIVE MOTOR AND CONTINUE TO DRIVE. THIS REPORTEDLY CAUSED THE END-USER TO LOSE CONTROL OF THEIR MANUAL WHEELCHAIR WHICH RESULTED WITH THEM LOSING POSITIONING AND FALLING OUT OF SEATING WHERE THEY SUSTAINED SOME BRUISING TO THE THIGH AND ABRASIONS TO THEIR UPPER APPENDAGES. THE END-USER REPORTED THEY PRESSED THE BUTTON MULTIPLE TIMES AND RECEIVED NO RESPONSE. AT THIS TIME, PERMOBIL AB HAS YET TO RECEIVE THE SUSPECT SWITCH CONTROL FOR INSPECTION, THUS IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE FOR THE ALLEGED FAILURE TO DISENGAGE DRIVE. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. REVIEW OF THE DHR INDICATES THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING AS THE END-USER WAS UNDER POWER WITH A SMARTDRIVE DEVICE USING SWITCH CONTROLS. IT WAS REPORTED WHEN PRESSING THE SWITCH CONTROL TO DISENGAGE THE DRIVE MOTOR, THE DEVICE REPORTEDLY FAILED TO STOP. THIS REPORTEDLY CAUSED THE END-USER TO FALL OUT OF THEIR MANUAL WHEELCHAIR RESULTING IN MINOR INJURIES. NO MEDICAL INTERVENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609654 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown