BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 24462427 · Received February 26, 2026

    Report

    Report Number
    3008370857-2026-00326
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT CLAIMS THE SMARTDRIVE DEVICE ENGAGED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH CONTROLS. PERMOBIL HAS REQUESTED THE SWITCH CONTROLS BE RETURNED TO PERMOBIL AB FOR EVALUATION IN EFFORT TO DETERMINE A PROBABLE CAUSE FOR THE ALLEGED MALFUNCTION. THE END-USER IS BEING PROVIDED A REPLACEMENT SET OF SWITCH CONTROLS, BUT SUSPECT CONTROLS HAVE YET TO BE RECEIVED AT PERMOBIL AB AS OF THIS REPORT DATE. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REPORTS WHILE SITTING IN A CLASSROOM AT SCHOOL, THE SMARTDRIVE DEVICE REPORTEDLY ENGAGED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH CONTROL BUTTONS. THIS REPORTEDLY FORCED THE WHEELCHAIR INTO A DESK WHERE THE END-USER SUSTAINED SOME BRUISING TO THEIR CHEST. NO MEDICAL INTERVENTION WAS SOUGHT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85868 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown