BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 25174567 · Received May 14, 2026

    Report

    Report Number
    3008370857-2026-00338
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 14, 2026
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED A REPORT THAT CLAIMS THE END-USER'S PARTNER TOUCHED THE JACK OF THE BUDDY BUTTON, AND THIS REPORTEDLY CAUSED THE SMARTDRIVE TO ENGAGE A DRIVE COMMAND. CLAIMS HAVING PRESSED THE BUDDY BUTTON TO DISENGAGE THE DRIVE MOTOR BUT DID NOT STOP THE SMARTDRIVE. REPORTS INDICATE THE SERVICE PROVIDER WAS UNABLE TO REPLICATE THE ALLEGED MALFUNCTION DURING INSPECTION. PERMOBIL AB HAS REQUESTED THE SUSPECT COMPONENT BE RETURNED FOR EVALUATION, AND AT THIS TIME PERMOBIL HAS NOT RECEIVED ANY PRODUCT AND 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

    RECEIVED REPORT CLAIMING WHILE USING THE SMARTDRIVE WITH A SWITCH CONTROL W/MONO JACK AND A BUDDY BUTTON, THEIR PARTNER REPORTEDLY TOUCHED THE CONNECTION PLUG WHERE THE BUDDY BUTTON PLUGS IN AND THIS REPORTEDLY CAUSED THE SMARTDRIVE DEVICE TO ENGAGE A DRIVE COMMAND. REPORTS CLAIM IT CAUGHT THE END-USER OFF GUARD WHERE THEY LOST POSITIONING AND FELL FROM THE WHEELCHAIR. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12189 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1