BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 15220467 · Received August 12, 2022

    Report

    Report Number
    3014522447-2022-00002
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 12, 2022
    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

    MOBIUS MOBILITY INVESTIGATION: DEVICE WAS RETURNED TO MOBIUS MOBILITY. BLACK BOX AND EVENT LOGS WERE RETRIEVED, AND THE DEVICE ELECTRONICS AND SYSTEMS WERE FUNCTIONING AS EXPECTED. THE DATA WAS CONSISTENT WITH LOSS OF CONTROL OF THE IBOT WHILE DESCENDING THE STAIRS. THE ATTENDANT HANDLE HAD BEEN REMOVED FOR TRANSIT IN A SMALL CAR, AND IT WAS NOT FULLY AND PROPERLY REINSTALLED WITH ALL THE REQUIRED PARTS. THIS WOULD MAKE IT POSSIBLE FOR THE ATTENDANT HANDLE TO SLIDE OUT IF IT WAS NOT LATCHED IN PLACE. IMAGES OF THE DEVICE JUST PRIOR TO THE INCIDENT SHOW THAT THE HANDLE WAS NOT IN A LATCHED POSITION. THE LACK OF CORRECT INSTALLATION AND THE HANDLE NOT BEING IN THE LATCHED POSITION FOR STAIR CLIMBING RESULTED IN THE HANDLE DETACHMENT.

    Description of Event or Problem · 0

    DURING AN ASSISTED STAIR CLIMBING DEMONSTRATION ON (B)(6) 2022, THE ATTENDANT HANDLE USED FOR STAIR CLIMBING CAME DETACHED RESULTING IN THE PERSON IN THE IBOT FALLING DOWN SEVERAL STEPS. THE DEVICE OCCUPANT WAS NOT SERIOUSLY INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070755 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention