BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 22923766 · Received August 29, 2025

    Report

    Report Number
    3014522447-2025-00008
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 29, 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 CAREGIVER REGARDING A STAIR-RELATED INCIDENT RESULTING IN INJURY. THE DEVICE WAS NOT RETURNED; HOWEVER, THERE WAS ACCESS TO RETRIEVE EVENT LOGS AND BLACK BOX DATA REMOTELY ON (B)(6) 2025. ADDITIONALLY, ON (B)(6) 2025 MOBIUS MOBILITY WAS ABLE TO EVALUATE AND TEST THE DEVICE AT THE USERS HOME AND CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE DEVICE. THE INVESTIGATION WAS CONDUCTED BY ON SITE TESTING OF THE IBOT INVOLVED IN THE REPORTED INCIDENT, AND REVIEWING SERVICE NOTES, DEVICE DATA AND REVIEW OF THE PRODUCTION & PATIENT RECORDS. DUE TO DATA WRAPPING AND LIMITATION OF EVENT LOG MEMORY CAPACITY, ONLY ALARM LOG DATA IS AVAILABLE FOR THE DATE INVOLVING THE REPORTED INCIDENT AT THE TIME OF ACCESSING THE DATA ON THE DEVICE. AT 13:06:34 GMT ON (B)(6) 2025 THE DEVICE REPORTED A CONTROLLER FAILURE CONDITION DUE TO PITCH LIMIT EXCEEDED. NO OTHER ALARM DATA IS PRESENT IN THE LOGS RELEVANT TO THE REPORTED INCIDENT. BASED ON THE EVALUATION/TESTING OF THE DEVICE AND THE LIMITED DATA AVAILABLE, NO DEVICE MALFUNCTION IS INDICATED IN THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    AN IBOT USER CALLED ON (B)(6) 2025, TO REPORT THEY HAD AN INCIDENT IN STAIR MODE RESULTING IN AN INJURY. THE IBOT OCCUPANT BROKE HIS FIBULA & TIBIA, AFTER THE DEVICE TIPPED OVER ON THE STAIRS DURING AN ASSISTED STAIR CLIMB. THE ASSISTANT ALSO FELL DURING THE EVENT RESULTING IN NO INJURIES THAT REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222598 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization