BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 11703587 · Received April 21, 2021

    Report

    Report Number
    3014522447-2021-00002
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 1, 2021
    Manufacturer
    MOBIUS MOBILIYT LLC.
    Product Code
    IMK
    UDI-DI
    00857584008003
    PMA / PMN Number
    K172601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE SHOWING THE IBOT® PMD TO A FRIEND, THE USER WAS DRIVING ON WET GRASS IN BALANCE MODE TO TRY TO FORCE AN AUTO TRANSITION AS A DEMONSTRATION OF THIS SAFETY FEATURE. USING BALANCE MODE ON WET SURFACES IS WARNED AGAINST DURING TRAINING AND IN THE MANUAL: "WARNING NEVER TRANSITION INTO, OR DRIVE IN BALANCE MODE ON WET, UNEVEN, UNSTABLE OR SLIPPERY SURFACES. THE IBOT® PMD USES TRACTION TO MAINTAIN ITS BALANCE, AND COULD SLIP ON SOME SURFACES." WHEN THE DEVICE NEVERTHELESS MAINTAINED TRACTION AND REMAINED IN BALANCE MODE, THE USER WENT INTO THE MENU AND INITIATED A FORCED POWER OFF, WHICH RESULTED IN THE DEVICE TIPPING OVER. THE FALL RESULTED IN THE USER BREAKING HIS TOE. THIS IS ALSO WARNED AGAINST DURING TRAINING AND IN THE MANUAL: "WARNING OPERATING THE FORCED POWER OFF WHEN IN BALANCE OR STAIR MODE CAN CAUSE THE DEVICE TO FALL OVER. THE DEVICE WILL FALL UNLESS SOMEONE IS CAPABLE OF KEEPING IT UPRIGHT IN BALANCE MODE OR YOU OR YOUR ASSISTANT CAN HOLD ONTO THE HANDRAIL OR ASSIST HANDLE IN STAIR MODE." THE USER INDICATED THAT HE KNOWS AND UNDERSTANDS THE INCIDENT WAS "USER ERROR" AND NOT DUE TO A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    USER REPORTED THAT HE WENT INTO THE MENU AND INITIATED A FORCED POWER OFF WHILE IN BALANCE MODE, WHICH RESULTED IN THE DEVICE TIPPING OVER. THE FALL RESULTED IN THE USER BREAKING HIS TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596093 IBOT PMD IBOT IMK MOBIUS MOBILIYT LLC. IBOT PMD N/A 00857584008003

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention