BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 16886448 · Received May 8, 2023

    Report

    Report Number
    3014522447-2023-00001
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    January 20, 2023
    Report Date
    May 8, 2023
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    UDI-DI
    00857584008010
    PMA / PMN Number
    K210920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER CONTACTED MOBIUS SHORTLY AFTER THE EVENT, AS THE FALL RESULTED IN A REMOTE CODE APPEARING ON THE IBOT. THIS IS EXPECTED DEVICE BEHAVIOR IN THE EVENT OF A FALL. THE USER, WHO WAS NOT YET AWARE OF THE INJURY, REPORTED TO MOBIUS STAFF THAT NO INJURY HAD OCCURRED. MOBIUS STAFF CLEARED THE CODE REMOTELY. AT A LATER DATE, THE USER CONTACTED MOBIUS FOR A SERVICE REQUEST UNRELATED TO THIS INCIDENT. AT THAT TIME, HE MENTIONED IN PASSING HAVING BROKEN A LEG WHEN HE CAUGHT A WHEEL AND FELL WHILE IN BALANCE MODE ON A CRUISE SHIP. MOBIUS STAFF CONFIRMED WITH HIM THAT THIS WAS THE SAME EVENT FOR WHICH HE HAD PREVIOUSLY REPORTED NO INJURY. MOBIUS RETRIEVED THE LOGS FROM HIS DEVICE. NO DEVICE MALFUNCTION WAS INDICATED IN THE LOGS. ASSESSMENT OF THE LOGS CORROBORATED THE USER'S ACCOUNT THAT A FALL HAD OCCURRED, AND INDICATED THAT THE FALL WAS DUE TO USER ERROR. THE USER MANUAL WARNINGS STATE TO "AVOID OBSTACLES, SLICK SURFACES, OR EXCESSIVE ROCKING WHEN IN BALANCE MODE."

    Description of Event or Problem · 0

    THE USER REPORTED BEING IN BALANCE MODE ON A CRUISE SHIP, AND CATCHING A WHEEL ON SOMETHING, CAUSING THE DEVICE TO GO OVER SIDEWAYS. THIS RESULTED IN THE USER BREAKING THEIR LEG, WHICH, DUE TO THEIR MEDICAL CONDITION, THEY DID NOT FEEL AND THEREFORE DID NOT REALIZE AT THE TIME THAT THEY HAD SUSTAINED AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764821 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention