BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 23043376 · Received September 12, 2025

    Report

    Report Number
    3008370857-2025-00202
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    June 23, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING THE END-USER HAVING MULTIPLE INSTANCES WHERE AN UNIDENTIFIED WATCH WOULD NOT REGISTER A COMMAND TO DISENGAGE THE SMART DRIVE MOTOR WHEN GIVEN TAPPING GESTURES. THE END-USER REPORTEDLY RETURNED THE SMARTDRIVE TO THE VENDOR, BUT NO REPORTS WERE SUBMITTED TO PERMOBIL UNTIL 2MO LATER. THE VENDOR WAS UNABLE TO PROVIDE PERMOBIL ANY IDENTIFYING INFORMATION RELATED TO THE SMART DRIVE DEVICE, OR THE SUSPECT WEARABLE THAT WAS REPORTED TO HAVE BEEN INOPERABLE. WITH THE LIMITED INFORMATION PROVIDED, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT SPECULATION. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 DRIVE MOTOR CONTINUES TO RUN. NO INJURIES OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169928 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown