BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 23974007 · Received January 6, 2026

    Report

    Report Number
    3008370857-2026-00050
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 8, 2025
    Report Date
    February 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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL RECEIVED SMARTDRIVE MX2+ FOR EVALUATION, AND IT WAS NOTED THE WIRELESS CONTROLLER (APPLE WATCH) THAT WAS REPORTED AS BEING IN USE WHEN THE ALLEGED EVENT OCCURRED WAS NOT RETURNED WITH THE SMARTDRIVE DEVICE, AND EVALUATION WAS CONDUCTED WITH IN-HOUSE TEST CONTROLLERS. EVALUATION OF THE SMARTDRIVE DEVICE WAS UNABLE TO REPLICATE THE ISSUE OF INVOLUNTARY MOVEMENT/ACTIVATION AS ALLEGED TO HAVE OCCURRED. THE DEVICE RESPONDED NORMALLY GIVEN COMMANDS VIA WIRELESS AND WIRED CONTROLLER OPTIONS. PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE FOR THE REPORTED EVENT WITHOUT SPECULATION. SUSPECT DEVICE WAS OPERATIONALLY TESTED SATISFACTORY AND RETURNED TO DEALER/PROVIDER.

    Additional Manufacturer Narrative · 0

    THE END-USER CLAIMS WHEN THEY PERFORMED A DOUBLE TAP OF APPLE WATCH TO ENGAGE A DRIVE COMMAND OF THE SMARTDRIVE DEVICE, CLAIMS IT SOUNDED AS IF THE MOTOR IS ENGAGING BUT THE UNIT DOES NOT MOVE. THEN, AFTER A SHORT AMOUNT OF TIME, THE MOTOR REPORTEDLY ENGAGED CATCHING THE USER OFF GUARD. PROVIDER TO SCHEDULE WITH END-USER TO HAVE SMARTDRIVE DEVICE AND CONTROLLER RETURNED TO PERMOBIL FOR EVALUATION. AT THIS TIME, PERMOBIL IS UNABLE TO CONFIRM A PRODUCT MALFUNCTION HAS OCCURRED AS ALLEGED AS NO PRODUCT HAS BEEN RETURNED. PERMOBIL WILL CONTINUE TO INVESTIGATE, AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE END-USER REPORTS WHEN THEY PERFORM A DOUBLE TAP WITH THEIR APPLE WATCH TO ENGAGE A DRIVE COMMAND, CLAIMS THE SMARTDRIVE SOUNDS AS IF THE MOTOR IS ENGAGING BUT THE UNIT DOES NOT MOVE. THEN, AFTER A SHORT AMOUNT OF TIME, THE MOTOR WILL ENGAGE CATCHING THE USER OFF GUARD. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39052 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown