BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 23782227 · Received December 11, 2025

    Report

    Report Number
    3008370857-2025-00461
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    August 12, 2025
    Report Date
    December 11, 2025
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT WAS RECEIVED VIA A SOLICITOR REPRESENTING THE END-USER. CLAIMS RECEIVED INDICATE WHEN GIVEN A TAPPING MOTION VIA THE APPLE WATCH TO DISENGAGE THE DRIVE MOTOR OF THE SMARTDRIVE MX2+, THE DEVICE CONTINUED TO DRIVE. REPORTS CLAIM THE END-USER FORCED THE WHEELCHAIR TO TIP ON TO SIDE TO AVOID MANEUVERING INTO ONCOMING TRAFFIC. REPORTS INDICATED THE END-USER SUSTAINED MINOR INJURIES TO THEIR FINGERS DESCRIBED AS FRICTION BURNS. NO SERIOUS INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED. AT TIME OF REPORT, PERMOBIL HAS BEEN UNABLE TO VERIFY A PRODUCT MALFUNCTION AS HAVING OCCURRED AS PRODUCT HAS NOT BEEN MADE AVAILABLE FOR INSPECTION. IF PERMOBIL RECEIVED ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING WHILE TRAVERSING OUT OF DOORS WHILE UNDER POWER OF THE SMARTDRIVE DEVICE, WHEN ATTEMPTING TO DISENGAGE THE DRIVE MOTOR VIA TAPPING GESTURES ON THE APPLE WATCH, THE DEVICE REPORTEDLY CONTINUED TO DRIVE WHICH FORCED THE END-USER TO TIP THEIR WHEELCHAIR ON TO ITS SIDE TO AVOID COLLISION WITH ONCOMING TRAFFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738751 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown