BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 17739163 · Received September 13, 2023

    Report

    Report Number
    3008370857-2023-00028
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 14, 2023
    Report Date
    October 10, 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

    PERMOBIL AB RECEIVED COMMUNICATION FROM THE END-USER REPORTING AN EVENT WHERE THEY ATTEMPTED TO DISENGAGE THE DRIVE ON THE SMARTDRIVE MX2+ DRIVE UNIT VIA TAPPING MOTION OF THE E2 TIC WATCH, BUT THE UNIT CONTINUED TO DRIVE. THE REPORT CLAIMS THEY REQUIRED ASSISTANCE FROM ANOTHER INDIVIDUAL TO TURN THE DEVICE OFF. NO INJURIES OCCURRED BECAUSE OF THIS EVENT. THE END-USER CLAIMS HAVING UPDATED THE MX2+ APP TO THE LATEST VERSION, AND AFTERWARDS CLAIMS THE APP SHUT DOWN WHICH ALLEGEDLY CAUSED THE DEVICE TO CONTINUE OPERATING. 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 CLAIMED THE APP HAVING CRASHED, AND THEY HAD UPDATED TO THE LATEST VERSION OF SOFTWARE, BUT PHOTO THEY PROVIDED INDICATED THEY UPDATED A DIFFERENT APPLICATION, NOT THE MX2+ APP. PERMOBIL AB IS CONTINUING TO INVESTIGATE THIS REPORTED ISSUE, AND 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 SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE END-USER CLAIMED THE MX2+ APP HAD CRASHED AFTER THEIR DEALER HAD UPDATED TO THE LATEST VERSION OF SOFTWARE, BUT THE PHOTO THEY INITIALLY PROVIDED INDICATED THEY HAD UPDATED A DIFFERENT APPLICATION, NOT THE MX2+ APP. THE END-USER LATER PROVIDED PERMOBIL AB WITH PHOTO EVIDENCE OF THE MX2+ APP HAVING BEEN UPDATED TO 1.1.00, WHICH IS THE CURRENT UPDATED VERSION, BUT THE END-USER MADE MENTION HAVING UPDATED THE APP ON AUGUST 16TH, 2 DAYS AFTER THE REPORTED EVENT OCCURRED. IT REMAINS UNCLEAR IF THE UPDATE THAT WAS REPORTED TO HAVE BEEN CONDUCTED PRIOR TO THE EVENT WAS ON THE MX2+ APP, OR THE PUSHTRACKER APP THAT WAS INITIALLY PROVIDED AS EVIDENCE. THE END-USER REPORTS HAVING CONTINUED USING THE SMARTDRIVE VIA THE E2 TIC WATCH SINCE THE EVENT AND HAS NOT HAD ANY RECURRING ISSUES. AS THE DEVICE IS REPORTED TO BE OPERATING NORMALLY WITH NO RECURRING ISSUES, AND END-USER BEING UNABLE TO CONFIRM IF THE MX2+ APP WAS UPDATED PRIOR TO THE EVENT, PERMOBIL IS UNABLE TO CONFIRM THE PROBABLE ROOT CAUSE OF THE EVENT WITHOUT SPECULATION.

    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, REQUIRING ASSISTANCE FROM ANOTHER PARTY TO TURN OFF THE SMARTDRIVE DEVICE. NO INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84147 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose