BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 23335210 · Received October 20, 2025

    Report

    Report Number
    3008370857-2025-00208
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 20, 2025
    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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AUSTRALIA RECEIVED A REPORT CLAIMING THE SPEED CONTROL DIAL HAVING INITIATED A DRIVE COMMAND WITHOUT ANY PHYSICAL MANIPULATION FROM THE END-USER. THIS ACTION REPORTEDLY FORCED THE END-USER TO MANEUVER THEIR WHEELCHAIR INTO AN IMMOVABLE OBJECT WHICH RESULTED IN THE END-USER LOSING UPRIGHT POSITIONING AND FALLING OUT OF THE SEATING WHERE THEY SUSTAINED BI-LATERAL FRACTURS TO THEIR LEGS. DUE TO AN INCREASE IN REPORTS OF SIMILAR FAILURES, CAPA 25-007 WAS IMPLEMENTED. INVESTIGATION FOUND A POTENTIAL ISSUE WHERE IF AN INTERMITTENT LOSS OF CONNECTION OCCURS BETWEEN THE SPEED CONTROL DIAL AND SMARTDRIVE ELECTRONICS, AN INVOLUNTARY ACTIVATION OF THE DRIVE MOTOR COULD OCCUR. FURTHER ENGINEERING ANALYSIS CONCLUDED THAT THIS ANOMALY WOULD ONLY OCCUR IF THE SPEED CONTROL DIAL WAS POWERED ON AND IN A FORWARD ROTATED DRIVE POSITION BUT IN STAND-BY MODE. IF THE CONNECTION IS LOST AND RE-INTRODUCED WHILE IN THIS POSITION, THE ELECTRONICS COULD POTENTIALLY INTERPRET THE RE-INTRODUCTION OF SIGNAL AS BEING A NEW COMMAND TO ENGAGE THE DRIVE MOTOR. AS THIS TYPE OF FAILURE CAN BE REPRODUCED AND HAS THE POTENTIAL TO OCCUR WITH ALL VERSIONS OF SPEED CONTROL DIAL, AS PART OF THE CAPA, PERMOBIL HAS IMPLEMENTED A PRODUCT RECALL FOR ALL SPEED CONTROL DIALS IN THE MARKET, Z-2538-2025, Z-2539-2025, Z-2540-2025. THE END-USER WILL BE PROVIDED WITH A SWITCH CONTROL BUTTON TO REPLACE THE AFFECTED SPEED CONTROL DIAL.

    Description of Event or Problem · 0

    REPORT CLAIMS THE SPEED CONTROL DIAL ENGAGED A DRIVE COMMAND ON THE SMARTDRIVE UNIT WITHOUT ANY PHYSICAL MANIPULATION FROM THE END-USER. THIS ACTION REPORTEDLY CAUSED THE USER TO COLLIDE INTO AN IMMOVEABLE OBJECT WHICH RESULTED IN A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820795 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization