BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 22612779 · Received July 25, 2025

    Report

    Report Number
    3014522447-2025-00007
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 25, 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

    ON (B)(6) 2025, MOBIUS MOBILITY WAS NOTIFIED BY THE USER'S MOTHER REGARDING A STAIR-RELATED INCIDENT RESULTING IN INJURY. THE DEVICE WAS NOT RETURNED; HOWEVER, WHILE COORDINATING ACCESS TO RETRIEVE EVENT LOGS AND BLACK BOX DATA, THE SERVICE TEAM REMAINED IN CONTACT WITH THE FAMILY, WHO ALSO PROVIDED VIDEO FOOTAGE OF PRIOR STAIR USE ON THE SAME STAIRCASE. THE EVENT LOGS AND BLACK BOX DATA WERE RETRIEVED ON (B)(6) 2025. THE INVESTIGATION WAS CONDUCTED USING SERVICE NOTES, DEVICE DATA, AND THE VIDEO PROVIDED BY THE FAMILY. THE DATA FROM THE DEVICE SHOWS THAT WITHIN 2 MINUTES OF ENTERING STAIR MODE, AN EVENT OCCURRED IN WHICH THE DEVICE WENT INTO A CLUSTER SAFETY LOCK AND EXCEEDED IT'S ALLOWABLE PITCH LIMIT. 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. BASED ON THE DATA, A DEVICE MALFUNCTION IS NOT INDICATED, AND THE DATA IS CONSISTENT WITH LACK OF PITCH CONTROL DURING STAIR MODE OPERATION.

    Description of Event or Problem · 0

    MOBIUS MOBILITY WAS NOTIFIED OF AN INCIDENT INVOLVING THE IBOT WHEELCHAIR ON (B)(6) 2025. THE ASSISTANT INDICATED THAT WHEN THE IBOT WAS IN STAIR MODE, IT DESCENDED 3 STAIRS NORMALLY AND THEN TIPPED FORWARD AND FELL DOWN PART OF THE STAIRCASE. THE PERSON IN THE SEAT FELL AND HAD A FEW BRUISES AND SCRAPES. THE ASSISTANT WENT OVER THE TOP OF THE WHEELCHAIR AND LANDED ON HER SHOULDER AND HEAD. THE ASSISTANT WAS HOSPITALIZED, RECEIVING TREATMENT FOR 3 BROKEN RIBS, A BROKEN CLAVICLE, 2 FRACTURED VERTEBRAE AND A MILD CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174212 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Hospitalization