BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 21483528 · Received February 27, 2025

    Report

    Report Number
    3014522447-2025-00001
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 5, 2025
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    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 REVIEWED THE USER'S ORIGINAL DEVICE CONFIGURATION AND THE HISTORY OF SUPPORT CALL AND PARTS REQUESTS FROM THE USER. THE USER HAD SWING AWAY LEG RESTS WITH MEDIUM FOOTPLATES AND HEEL LOOPS. THERE WERE NO LEG STRAPS ON THE ORDER AND THERE WERE NO CALLS FROM THE USER INDICATING THAT THEY WERE HAVING ISSUES KEEPING THEIR FEET ON THE FOOT PLATE. IN REVIEWING THE TRAINING RECORD WITH THE ASSISTIVE TECHNOLOGY PROFESSIONAL THAT PERFORMED THE TRAINING, THE USER HAD NO ISSUES KEEPING HIS FEET ON THE FOOT PLATE WHEN MANEUVERING IN STANDARD, 4-WHEEL, BALANCE OR STAIR MODES. UNAPPROVED REPAIRS OR CHANGES TO THE LEG REST LENGTH ADJUSTMENT COULD RESULT IN THE LACK OF FOOT/LEG CONTROL WHEN USING THE DEVICE, CONTRIBUTING TO THE INCIDENT. MOBIUS MOBILITY'S QUALITY AND SERVICE TEAMS MADE 6 ATTEMPTS TO GET ADDITIONAL INFORMATION, TO OBTAIN THE DEVICE BLACK BOX DATA, AND TO HELP RESOLVE ANY ISSUES THAT THE USER WAS HAVING. THE USER RESPONDED TO EMAIL 2 TIMES INDICATING THAT THEY WOULD CALL US BACK THE NEXT DAY, BUT THEY NEVER CALLED OR RESPONDED TO EMAILED INVESTIGATION QUESTIONS.

    Description of Event or Problem · 0

    USER EMAILED INQUIRING IF MOBIUS MOBILITY ACCEPTED TRADE-INS OF OLDER MODELS FOR A NEW POWER POSITIONING SEAT. IN THE EMAIL THE USER LISTED SEVERAL COMPLAINTS ON PARTS THAT HAVE WORN OUT OR BROKEN OVER THE PAST 2 YEARS ON HIS CURRENT IBOT PMD. THE USER INDICATED THAT HE CORRECTED ALL THE LISTED ISSUES HIMSELF, LIKELY WITH UN-APPROVED PARTS. IN THE MIDDLE OF THE EMAIL HE ALSO INDICATING THAT THE "FOOTRESTS DESIGNED TO ALLOW MY FOOT TO FOLLOW BETWEEN THE PEDALS AND BREAKING MY TIBIA AND FIBULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030008 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention