BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 16955230 · Received May 18, 2023

    Report

    Report Number
    3008370857-2023-00012
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    March 8, 2023
    Report Date
    May 18, 2023
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE END-USER REPORTED UPON ATTEMPTING TO DISENGAGE THE DRIVE MOTOR OF THE SMARTDRIVE DEVICE VIA A DOUBLE TAP OF THE E2 SMART WATCH, THE DRIVE MOTOR CONTINUED TO RUN WHICH FORCED THE END-USER TO COLLIDE INTO A WALL TO STOP. THE END-USER DID NOT SUSTAIN 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. FOR THIS SPECIFIC CASE, THE END-USER DID NOT HAVE ANY RECOLLECTION OF THE STATE OF THE WATCH SCREEN OR NEED TO RE-START THE APPLICATION. PERMOBIL TECHNICIANS EVALUATED THE DEVICE, WITH THE E2 WATCH, AND FOUND THE DEVICE FULLY OPERATIONAL WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. PERMOBIL IS UNABLE TO CONFIRM A FAILURE HAVING OCCURRED THEREFORE, UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE OF THE REPORTED FAILURE WITHOUT SPECULATION. ALTHOUGH UNCONFIRMED, INFORMATION OUTLINED IN THE CAPA INVESTIGATION, BASED ON SYMPTOM, SUGGESTS THAT THE ALLEGATIONS RELATED TO FAILURE TO DISENGAGE DRIVE BY TAP GESTURES COULD BE AN ANR ERROR, WHICH IF TO REOCCUR, HAS THE POTENTIAL TO LEAD TO A SERIOUS INJURY. 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 IN A MALL, THEY REPORTED ATTEMPTING TO DISENGAGE THE DRIVE MOTOR VIA A TAPPING MOTION OF THE E2 SMART WATCH, AND THE DEVICE CONTINUED TO RUN FORCING THE END-USER TO PIN THE WHEELCHAIR AGAINST A WALL UNTIL THE MX2+ COULD BE TURNED OFF. NO INJURIES WERE SUSTAINED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995242 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose