BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 21734769 · Received March 31, 2025

    Report

    Report Number
    3014522447-2025-00002
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 31, 2025
    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 INTERVIEWED THE USER AND RETRIEVED THE EVENT/ALARM DATA AND BLACK-BOX DATA FROM THE DEVICE. THE DATA CONFIRMS THAT ON 3/12/25, AT 13:11:00, THE DEVICE ROLL LIMIT WAS EXCEEDED WHILE IN 4-WHEEL MODE, INDICATING FAILURE OF THE OPERATOR TO PROPERLY CONTROL THE DEVICE. BLACK BOX DATA SHOWS THE DEVICE MOVING FORWARD ON LEVEL GROUND IN 4-WHEEL MODE, THEN DECELERATING. THE CLUSTER ANGLE DIPS JUST PRIOR TO THE ROLL ANGLE INDICATING THE TIP. THE DATA IS CONSISTENT WITH THE USER DESCRIPTION OF NOT GOING OFF THE CURB STRAIGHT CAUSING THE DEVICE TO TIP OVER SIDEWAYS. 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.

    Description of Event or Problem · 0

    USER'S WIFE CALLED INDICATING HER HUSBAND HAD TIPPED OVER SIDEWAYS IN HIS IBOT WHILE AWAY ON VACATION. SHE SAID HE WAS GOING OFF A CURB WITH A GLASS IN HIS HAND AND TIPPED THE DEVICE OVER, BREAKING THE GLASS, WHICH RESULTED IN A SMALL CUT. THE CUT FROM THE GLASS RESULTED IN 4 STICHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912564 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention