BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 23809983 · Received December 15, 2025

    Report

    Report Number
    3014522447-2025-00010
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 15, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSISTANT WAS DESCENDING THE STAIRS WITH THE USER IN THE WHEELCHAIR AT THE TIME OF THE EVENT. THEY HAD NOT USED THE STAIR CLIMBING FEATURE IN 6 MONTHS. FROM THE DESCRIPTION OF THE EVENT AND EMAILS WITH THE AUTHORIZED REPRESENTATIVE, IT APPEARS THAT THE USER'S ASSISTANT MAY HAVE LOST CONTROL OF THE DEVICE AT OR NEAR THE BOTTOM OF THE STAIRS, RESULTING IN A FALL FORWARD AT THE BASE OF THE STAIRS. MOBIUS MOBILITY RETRIEVED LOGS AND EVENT DATA FROM THE USER'S DEVICE FOR REVIEW OF THE INCIDENT. NO DEVICE MALFUNCTION IS INDICATED IN THIS DATA. A CLUSTER SAFETY LOCK WAS RECORDED. A CLUSTER SAFETY LOCK IS WHEN THE DEVICE STOPS CLUSTER ROTATION UPON DETECTION OF LOSS OF PITCH CONTROL BY THE USER OR ASSISTANT DURING STAIR CLIMBING OR DESCENDING. A CLUSTER SAFETY LOCK IS INTENDED TO STOP MOVEMENT IN A POTENTIALLY UNSAFE SITUATION AND AID THE USER OR ASSISTANT IN CORRECTING THE PITCH. IF THE PITCH IS NOT CORRECTED IN A TIMELY MANNER THE DEVICE CAN FALL FORWARD. THE DEVICE OPERATED AS DESIGNED AND ASSISTANT ERROR IS SUSPECTED, AS WE RECOMMEND USING THE STAIR CLIMBING FEATURE REGULARLY TO KEEP A LEVEL OF FAMILIARITY IN CONTROLLING THE DEVICE ON THE STAIRS.

    Description of Event or Problem · 0

    ACCIDENT OCCURS INDOORS GOING DOWNSTAIRS. USER HAD AN ASSISTANT DURING THIS EVENT. ON THE LAST STEP OF THE STAIRS THE CHAIR GOES UP ON TWO WHEELS AND INSTEAD OF CLIMBING DOWN IT FELL FACE FRONT ON A DOOR INFRONT OF THE STAIRS. THE USER'S RESULTING IN AN ANKLE FRACTURE ON THE LEFT AND A TARSAL FRACTURE AND A HEAD INJURY. THE USER WAS FASTENED IN A BELT. THEY HAD GONE UP THE STAIRS PRIOR WITHOUT ANY DIFFICULTIES. THEY HAD NOT USED THE STAIR CLIMBER IN 6 MONTHS BEFORE THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789896 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization