BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 25285057 · Received May 26, 2026

    Report

    Report Number
    3008370857-2026-00340
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED A REPORT WHERE IT WAS ALLEGED THAT WHILE USING THE SMARTDRIVE WITH SWITCH CONTROL BUTTON W/MONO JACK AND A BUDDY BUTTON, THE CONTROLS WERE REPORTEDLY OFF YET CLAIMS THE DEVICE ENGAGED A DRIVE COMMAND, INVOLUNTARILY, WHICH FORCED THE END-USER TO COLLIDE INTO AN IMMOVABLE OBJECT WHERE THEY LOST POSITIONING AND FELL FROM THE WHEELCHAIR. THE FALL REPORTEDLY REQUIRED A HOSPITAL VISIT, BUT THE EXTENT OF INJURY AND LEVEL OF MEDICAL INTERVENTION WAS NOT DISCLOSED. PERMOBIL AB HAS REQUESTED FURTHER INFORMATION FROM REPORTER, BUT HAS YET TO RECEIVE ANY RESPONSE AT THIS TIME. THE SMARTDRIVE DEVICE AND CONTROLLER WAS REPORTEDLY RETREIVED BY THE PROVIDER FOR INSPECTION, BUT NO INFORMATION HAS BEEN PROVIDED TO PERMOBIL AB AS TO THEIR FINDINGS. PERMOBIL AB HAS REQUESTED SUSPECT COMPONENTS BE RETURNED TO PERMOBIL AB FOR FURTHER EVALUATION. AT THIS TIME, PERMOBIL AB IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT SPECUALTION. UPON RECEIPT OF ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING AS THE END-USER WAS USING THE SMARTDRIVE DEVICE WITH A SWITCH CONTROL BUTTON W/MONO JACK AND BUDDY BUTTON, REPORTED THAT THE DEVICE HAD BEEN SWITCHED OFF, BUT THE END-USER'S WHEELCHAIR REPORTEDLY TOOK OFF AND COULDN'T BE STOPPED. THE END-USER HAD TO CRASH INTO A BIN IN ORDER TO STOP IT. IT WAS FURTHER REPORTED THAT THE CLIENT FELL FROM THE WHEELCHAIR WHERE THEY REPORTEDLY SUSTAINED AN UNSPECIFIED INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363818 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1