BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 17685998 · Received September 5, 2023

    Report

    Report Number
    3008370857-2023-00025
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    July 1, 2021
    Report Date
    September 5, 2023
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE END-USER, THE EVENT OCCURRED IN (B)(6) OF 2021, BUT THEY WERE UNSURE OF THE EXACT DATE. REPORT CLAIMS THE END-USER ATTEMPTED TO STOP THE SMARTDRIVE DEVICE VIA A DOUBLE TAP OF THEIR E2 TIC WATCH, BUT THE DEVICE CONTINUED TO DRIVE, AND THEY ROLLED DOWN TWO STEPS INTO A SUNKEN LIVING ROOM. THIS REPORTEDLY RESULTED IN AN FX TO THE PELVIS AND AN UNDISCLOSED SHOULDER INJURY. THE END-USER STATED THIS EVENT OCCURRED WITH AN OLDER SMART DRIVE MX2+ UNIT THEY HAD OWNED PRIOR TO THE DEVICE THEY IDENTIFIED WHEN CONTACTING PERMOBIL. THE END-USER STATED THEY WERE NO LONGER IN POSSESSION OF THE SUSPECTED MX2+ DEVICE OR E2 TIC WATCH. PERMOBIL IS UNABLE TO IDENTIFY THE SPECIFIC DEVICE WITHOUT A SERIAL NUMBER AS THERE ARE NO RECORDS TIED TO THE END-USER BY NAME. THE END-USER STATED THEY HAVE NO RECOLLECTION IF THE MX2+ APP WAS IN FOCUS WHEN THE EVENT OCCURRED. 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. AS END-USER HAD NO RECOLLECTION IF THE APP WAS IN FOCUS, AND THE SUSPECT DEVICE AND CONTROLLER ARE NO LONGER AVAILABLE FOR INSPECTION, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT SPECULATION.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING WHILE USING THE SMARTDRIVE MX2+, THE END-USER ATTEMPTED TO STOP THE DEVICE VIA A DOUBLE TAP OF THEIR E2 SMART WATCH, BUT THE DEVICE REPORTEDLY CONTINUED TO DRIVE, FORCING THE END-USER TO PROPEL DOWN TWO STEPS INTO A SUNKEN LIVING ROOM WHERE THEY SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007313 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization