BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 19288554 · Received May 10, 2024

    Report

    Report Number
    3008370857-2024-00008
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 10, 2024
    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

    PERMOBIL AB RECEIVED COMMUNICATION VIA SOCIAL MEDIA, FROM THE END-USER, REPORTING AN EVENT WHERE THEY ATTEMPTED TO DISENGAGE THE DRIVE MOTOR ON THE SMARTDRIVE MX2+ DRIVE UNIT VIA TAPPING MOTION ON THEIR SAMSUNG GALAXY SMART WATCH, BUT THE UNIT CONTINUED TO DRIVE. THE REPORT CLAIMS THE END-USER IMPACTED ANOTHER WHEELCHAIR USER, BUT NEITHER THE END-USER NOR OTHER PARTY RECEIVED ANY INJURIES AS A RESULT. DURING THE VALIDATION OF A PENDING DESIGN CHANGE TO PROVIDE THE SMARTDRIVE MX2+ APPLICATION FOR ANDROID WEARABLES, ENGINEERING IDENTIFIED A MISSING CODE IN THE APPLICATION RELATED TO ANR (APPLICATION NOT RESPONDING) WHERE IF THE APPLICATION CRASHES DUE TO AN ANR, THE ERROR HANDLING LOGIC FAILS TO STOP THE BLUETOOTH COMMUNICATION TO THE SMARTDRIVE MX2+ DRIVE UNIT. AS A RESULT, THE MOTOR CONTINUES TO RUN, AND THE USER MAY NOT BE ABLE TO DISENGAGE THE DEVICE USING TAP GESTURES. A CAPA INVESTIGATION, 23-002, WAS OPENED TO ADDRESS THIS ISSUE. AS PART OF THE INVESTIGATION, IT WAS DETERMINED THE WAY TO IDENTIFY IF AN ANR EVENT OCCURRED COULD BE DETECTED BY THE SCREEN ON THE WEARABLE. IF IT IS REPORTED THE SCREEN IS BLANK/DARK DURING OR JUST AFTER THE EVENT, OR IF THE END-USER RECALLS THE NEED TO RESTART THE MX2+ APPLICATION TO RESTORE OPERATION, THESE ACTIONS WILL INDICATE A POSSIBLE ANR CRASH HAVING OCCURRED. THE END-USER REPORTS HAVING RECENTLY PURCHASED THE GALAXY WATCH AND INSTALLED THE LATEST FIRMWARE, BUT DOES NOT RECALL IF THE APP REMAINED IN FOCUS WHEN THE EVENT OCCURRED. REPORTS INDICATE THE SMARTDRIVE DEVICE REMAINS FULLY OPERATIONAL, AND IS CURRENTLY BEING USED. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING WHILE THE END-USER WAS USING THEIR SMARTDRIVE MX2+ DEVICE, THEY REPORTED ATTEMPTING TO DISENGAGE THE DRIVE MOTOR VIA A TAPPING MOTION OF THEIR GALAXY SMART WATCH, AND THE DEVICE CONTINUED TO RUN. THIS REPORTEDLY CAUSED THE END-USER TO MANEUVER INTO ANOTHER WHEELCHAIR USER. NO SERIOUS INJURIES WERE SUSTAINED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520200 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose