BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 14118348 · Received April 15, 2022

    Report

    Report Number
    3014522447-2022-00001
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 12, 2022
    Report Date
    April 15, 2022
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    UDI-DI
    00857584008003
    PMA / PMN Number
    K172601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MOBIUS MOBILITY INVESTIGATION: THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO MOBIUS MOBILITY, HOWEVER THE EVENT LOGS, FAULT CODE DATA, AND BLACK BOX DATA WERE RETRIEVED BY THE MOBIUS MOBILITY SERVICE TEAM. THE HOMEOWNER'S SECURITY CAMERA FOOTAGE WAS ALSO PROVIDED TO MOBIUS MOBILITY FOR REVIEW. A FAILURE INVESTIGATION WAS PERFORMED USING THE DATA AND VIDEO FOOTAGE. THE DATA FROM THE DEVICE SHOWS THAT 55 SECONDS AFTER ENTERING STAIR MODE, AN EVENT OCCURRED IN WHICH THE DEVICE WENT INTO CLUSTER SAFETY LOCK AND EXCEEDED ITS PITCH LIMIT. CLUSTER SAFETY LOCK IS THE DEVICE'S DETECTION OF A LOSS OF PITCH CONTROL BY THE USER OR ASSISTANT DURING STAIR CLIMBING. PRIOR TO THIS EVENT, THE DATA SHOWS A PORTION OF STEP DESCENT WITH ADEQUATE PITCH CONTROL (BRAKING), THEN A 5 SECOND PERIOD OF FORWARD PITCH INPUT THAT CAUSES RAPID DEVICE MOVEMENT IN THE DESCENDING DIRECTION. THE PITCH IS NOT ADEQUATELY CONTROLLED BY THE ASSISTANT, RESULTING IN THE EVENT. THE DEVICE DATA LOGS ARE CONSISTENT WITH THE REPORTED INCIDENT AND THE USER'S VIDEO. NO OTHER ALARMS WERE PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THE EVENT. THE CAUSE OF THE INCIDENT IS MOST ATTRIBUTED TO THE ASSISTANT'S IMPROPER FOOT PLACEMENT (STANCE) ON THE 1ST STEP DOWN FROM THE LANDING, AS SHOWN IN THE VIDEO, WHICH DID NOT ALLOW FOR PROPER PITCH CONTROL OF THE DEVICE. FOLLOWING THE INCIDENT, THE LOGS SHOW THE DEVICE WAS POWERED OFF/ON AND CONTINUED TO OPERATE NORMALLY WITH "SERVICE REQUIRED" FLAG SET, WHICH LIMITS DEVICE FUNCTIONALITY DISABLING STAIR MODE. THIS IS EXPECTED DEVICE BEHAVIOR AFTER THE DEVICE EXCEEDS ITS PITCH LIMIT. THUS, THE DEVICE DID NOT MALFUNCTION AND PERFORMED AS EXPECTED.

    Description of Event or Problem · 0

    ON 03/29/2022 THE USER CALLED MOBIUS MOBILITY TO REPORT AN INCIDENT INVOLVING THE IBOT® PMD WHICH OCCURRED ON (B)(6) 2022. THE USER WAS SEATED IN THE IBOT® PMD WHILE BEING ASSISTED DOWN THE STEPS BY HIS WIFE, WHO HAS PASSED MOBIUS MOBILITY'S ASSISTED STAIR TRAINING, AND HAD AN EVENT RESULTING IN HIM BEING EJECTED FROM THE DEVICE. USER STATED HE WAS NOT WEARING THE PROVIDED LAP BELT AT THE TIME OF THE EVENT AS ADVISED IN ACCOMPANYING DEVICE LABELING. THE USER REPORTED HE SUSTAINED A CONCUSSION AND A LACERATION ON HIS TONGUE WHICH REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907562 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008003

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention