BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 22926528 · Received August 29, 2025

    Report

    Report Number
    3008370857-2025-00201
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    April 16, 2025
    Report Date
    August 29, 2025
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING THE END-USER HAVING MULTIPLE INSTANCES WHERE THE E3 TIC WATCH WOULD NOT REGISTER A COMMAND TO DISENGAGE THE SAMRT DRIVE MOTOR WHEN GIVEN TAPPING GESTURES. REPORTS CLAIM WHEN THIS OCCURS, THE END-USER MUST USE THE WIRED SWITCH BUTTONS TO DISENGAGE. REPORTS CLAIMED THE USER TRIED A DIFFERENT WEARABLE (UNKNOWN AS TO TYPE) AND HAD THE SAME ISSUE OF NOT REGISTERING THE TAP GESTURES. THE END-USER REPORTEDLY RETURNED THE SMARTDRIVE TO THE VENDOR, BUT NO REPORTS WERE SUBMITTED TO PERMOBIL UNTIL 4MO LATER. THE SUSPECT E3 WAS REPORTED TO HAVE BEEN DISCARDED RENDERING PERMOBIL UNABLE TO CONFIRM COMPLAINT AS ALLEGED. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED REPORT WHERE IT WAS CLAIMED WHEN USING THE E3 TIC WATCH, ON OCCASION WHEN ATTEMPTING TO STOP THE SMARTDRIVE DEVICE VIA A TAPPING MOTION, THE UNIT CONTINUED TO RUN FORCING THE END-USER TO UTILIZE A SWITCH CONTROL BUTTON TO STOP. NO INJURIES OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222809 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown