BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 24332627 · Received February 13, 2026

    Report

    Report Number
    3008370857-2026-00320
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT INDICATES A FAILURE HAVING OCCURRED WHERE THE SMART DRIVE DEVICE REPORTEDLY INITIATED A DRIVE COMMAND WITHOUT PHYSICAL MANIPULATION OF THE SWITCH CONTROLS. REPORT CLAIMS THE END-USER ATTEMPTED TO DISENGAGE A DRIVE COMMAND VIA THE SWITCH CONTROL BUTTONS AND THE DEVICE REPORTEDLY CONTINUED TO DRIVE. THIS REPORTEDLY FORCED THE END-USER TO MANEUVER THE WHEELCHAIR INTO AN IMMOVEABLE OBJECT WHERE THEY SUSTAINED MINOR BRUISING INJURIES TO THEIR LEGS. THE END-USER REPORTS THEY HAVE ONE SWITCH MOUNTED IN THE FRONT OF THE WHEELCHAIR FOR THEIR ACCESS, AND THE SECOND SWITCH MOUNTED TO THE PUSH HANDLE AREA FOR AN ATTENDANT. THE END-USER WAS PROVIDED A REPLACEMENT SET OF SWITCH CONTROLS, WITH THE SUSPECT CONTROLLER BEING RETURNED TO PERMOBIL FOR EVALUATION. AT THIS TIME, PERMOBIL HAS YET TO RECEIVE THE SUSPECT COMPONENT, THUS IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE CAUSE FOR THE ALLEGED MALFUNCTION. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A REVIEW OF THE DEVICE HISTORY RECORD FROM THE DATE THE DEVICE WAS MANUFACTURED WAS PERFORMED WHICH NOTED THAT THIS DEVICE WAS NOT INVOLVED IN MANUFACTURING QUALITY NON-CONFORMANCE.

    Additional Manufacturer Narrative · 0

    PERMOBIL RECEIVED SUSPECT CONTROLLER FOR INSPECTION AND EVALUATION. THROUGH TESTING, PERMOBIL WAS UNABLE TO REPLICATE ANY FAILURE OF INVOLUNTARY ACTIVATION AS ALLEGED, NOR NOTED ANY SIGNS OF A PRODUCT MALFUNCTION HAVING OCCURRED WITH THE SWITCH CONTROLLER, FINDING IT TO REMAIN FULLY OPERATIONAL AS PER DESIGN. PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE OF THE ALLEGED MALFUNCTION WITHOUT SPECULATION.

    Description of Event or Problem · 0

    REPORTS WHILE IN A GROCERY STORE, THE SMARTDRIVE UNIT ENGAGED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION OF THE SWITCH CONTROL BUTTON, REPORTEDLY CAUSING THE END-USER TO IMPACT AN IMMOVEABLE OBJECT WITH THE WHEELCHAIR. NO SERIOUS INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255879 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown