BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 23478994 · Received November 5, 2025

    Report

    Report Number
    3008370857-2025-00215
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 23, 2024
    Report Date
    November 5, 2025
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    861896000310
    PMA / PMN Number
    K151199
    Removal / Correction Number
    Z-2538-2025 THROUGH Z-25
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FAILURE MODE HAS BEEN PREVIOUSLY REPORTED PER 21 CFR 803.50. AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT RESULTING FROM IMPROVEMENTS MADE TO MAX MOBILITY'S COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES, CAPA 25-008 WAS IMPLEMENTED. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW. AS PART OF CORRECTIVE ACTIONS, MAX MOBILITY HAS INITIATED A FIELD ACTION RECALL FOR ALL SPEED CONTROL DIALS THAT ARE CURRENTLY IN USE. MAX MOBILITY WILL BE PROVIDING SWITCH CONTROL BUTTONS OR SWITCH CONTROL BUTTONS WITH MONO JACK OPTION TO REPLACE THE AFFECTED SPEED CONTROL DIALS.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING WHILE THE END-USER WAS USING THE SMARTDRIVE MX2+ DEVICE VIA A SPEED CONTROL DIAL, WHEN ROTATING THE DIAL BACK TO THE STAND-BY/NEUTRAL POSITION TO STOP, THE MOTOR WOULD NOT DISENGAGE AND CONTINUED TO RUN. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465211 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown