BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTDRIVE

    MDR report key: 18412423 · Received December 28, 2023

    Report

    Report Number
    3008370857-2023-00034
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    August 19, 2023
    Report Date
    December 28, 2023
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL RECEIVED A VOLUNTARY MEDWATCH REPORT, MW5147992, SUBMITTED BY THE END-USER. THE END-USER CLAIMS TO HAVE HAD MULTIPLE OCCASIONS WHERE THE E2 TIC WATCH WOULD FAIL TO RESPOND TO A DOUBLE TAP COMMAND TO STOP, AND THE DEVICE CONTINUED TO OPERATE. THE REPORTER CLAIMS TO HAVE RECEIVED THE MARKET CORRECTION LETTER, UPDATED TO THE LATEST VERSION AS PER INSTRUCTION, AND HAD CONTINUED TO HAVE ISSUES OF FAILURE TO DISENGAGE. REPORTS HAVING SWAPPED OVER TO AN APPLE 4 WATCH AND CLAIMS HAVING THE SAME ISSUE. THE END-USER DID NOT PROVIDE THE S/N TO IDENTIFY THE SPECIFIC DEVICE IN THE REPORT, THEREFORE PERMOBIL CANNOT CONFIRM THE PRODUCT. PERMOBIL HAS BEEN UNABLE TO ESTABLISH CONTACT WITH THE END-USER WITH THE INFORMATION PROVIDED, THUS IS UNABLE TO IDENTIFY THE DEVICE IN QUESTION TO VERIFY THE CLAIM AS PRESENTED. CURRENTLY, PERMOBIL IS UNABLE TO CONFIRM THE CLAIM, THUS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT SPECULATION. PERMOBIL WILL CONTINUE IN THEIR ATTEMPTS TO ESTABLISH CONTACT, AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PERMOBIL RECEIVED A VOLUNTARY MEDWATCH REPORT WHERE IT WAS CLAIMED THAT END-USER HAD MULTIPLE OCCASIONS WHERE THEY ATTEMPTED TO DISENGAGE THEIR SMARTDRIVE DEVICE VIA TAPPING OF THE E2 TIC WATCH, AND THE DEVICE FAILED TO RESPOND. NO INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED BECAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273850 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose