BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 17011348 · Received May 26, 2023

    Report

    Report Number
    3008370857-2023-00013
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 23, 2023
    Report Date
    July 24, 2023
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SMARTDRIVE MX2+ DEVICE AND E2 TIC WATCH WERE RETURNED TO PERMOBIL AB FOR EVALUATION. TESTING WAS CONDUCTED ON BOTH DEVICES WITH NO ISSUES BEING FOUND. BOTH THE E2 TIC WATCH AND SMARTDRIVE MX2+ UNIT OPERATED ACCORDING TO SPECIFICATION WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. WITH THE INFORMATION PROVIDED AND THE INABILITY TO RE-CREATE THE FAILURE AS DESCRIBED, PERMOBIL IS UNABLE TO CONFIRM A FAILURE HAVING OCCURRED THEREFORE, UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT SPECULATION. THE SUSPECT DEVICES HAVE BEEN RETURNED TO THE END-USER WITH NO FURTHER REPORTS BEING RECEIVED OF RECURRING BEHAVIOR.

    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 CAUSED THE END-USER TO PANIC AND LEAP FROM THE WHEELCHAIR SEATING. THE END-USER SUSTAINED SOME MINOR BRUISES 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. THE MX2+ DEVICE AND E2 SMART WATCH ARE BEING RETURNED TO PERMOBIL AB FOR EVALUATION. AT THE TIME OF THIS REPORT, THE SUSPECT DEVICES HAVE YET TO BE EVALUATED. AT THE COMPLETION OF THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH PERMOBIL'S FINDINGS. 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 THE E2 SMART WATCH, AND THE DEVICE CONTINUED TO RUN. THIS REPORTEDLY CAUSED THE END-USER TO PANIC, AND THEY LEAPED FROM THE WHEELCHAIR SEATING. NO SERIOUS INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886174 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose