BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBOT PMD

    MDR report key: 21985757 · Received May 8, 2025

    Report

    Report Number
    3014522447-2025-00003
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 12, 2025
    Report Date
    May 8, 2025
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    UDI-DI
    00857584008010
    PMA / PMN Number
    K243442
    Removal / Correction Number
    014522447/05052025/C/000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER STATES THAT SHE DID NOT INTENTIONALLY COMMAND MODE TRANSITION, BUT NEVERTHELESS, THE DATA SHOWS THE COMMANDS WERE RECEIVED. THE USER CONTROLLER WAS RETURNED FOR EVALUATION, AND NO ISSUES WERE IDENTIFIED WITH THE USER CONTROLLER. WHEREAS THE USER STATED SHE WAS LEANING HER ELBOW ON THE ARMREST, IT IS POSSIBLE SHE ACCIDENTALLY PRESSED THE MODE TRANSITION SHORTCUT AND SEAT ADJUSTMENT SHORTCUT. AS TO WHY THE DEVICE FELL, INVESTIGATION FOUND A SOFTWARE ISSUE IN THE RECENTLY-RELEASED SOFTWARE VERSION RUNNING ON THIS DEVICE. IF A SEAT ADJUSTMENT IS COMMANDED DURING A 24 MILLISECOND WINDOW OF A SELF-TEST WHICH OCCURS APPROXIMATELY 1 SECOND AFTER TRANSITION TO BALANCE MODE OR AFTER A SEAT ADJUSTMENT IN BALANCE MODE, TWO SELF-TESTS WILL INTERFERE WITH EACH OTHER, LEADING TO A TIP-OVER.

    Description of Event or Problem · 0

    USER STATED SHE WAS IN STANDARD MODE LEANING HER ELBOW ON THE ARMREST. THE DEVICE WAS STATIONARY ON LEVEL GROUND. THE USER HEARD A CLICK AS OF THE BRAKES RELEASING, AND THE IBOT MOVED AS IF TO TRANSITION MODES (INTO 4-WHEEL OR BALANCE MODE) AND THEN FELL OVER BACKWARDS. USER REPORTED THAT SHE DID NOT INTENTIONALLY COMMAND A MODE TRANSITION. USER WAS NOT WEARING THE POSITIONING BELT. SHE LANDED ON HER BACK, WITH HER HEAD ON THE HEADREST, AND SLID OUT OF THE SEAT. SHE DID NOT SUSTAIN ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945074 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female