BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 2253459 · Received September 12, 2011

    Report

    Report Number
    3003508375-2011-00004
    Event Type
    Other
    Date Received
    September 12, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 12, 2011
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO INSPECT THE DEVICE, RETRIEVE THE ELECTRONIC CONFIGURATION FILE (ECF) FOR EVAL, AND CLEAR THE SERVICE WRENCH. A FIELD SERVICE ACTIVITY / DEVICE CHECKOUT REPORT (ESAR) WAS FORWARDED TO THE COMPLAINT HANDLING UNIT (CHU) PER STANDARD OPERATING PROCEDURE. THE ESAR CONFIRMED THE REPORTED DAMAGE TO THE LIGHT ASSY AND LAP BELT WHICH WERE REPLACED IN A SEPARATE SERVICE ACTIVITY. THE DEVICE WAS DEEMED APPROPRIATE FOR USE. ECF ANALYSIS INDICATES THE DEVICE WAS IN BALANCE FUNCTION WITH THE SEAT HEIGHT AT MID-RANGE FOR APPROX. 1 HR 45 MINUTES, TRAVELING A DISTANCE OF 14 METERS WHEN A SERIES OF FRAME LEAN ADJUSTMENTS AND SEAT HEIGHT ADJUSTMENT RESULTED IN CLUSTER DRIVE AB REPORTING "WARM". ANOTHER SEAT HEIGHT ADJUSTMENT WAS MADE ELEVATING THE SEAT TO MAXIMUM, AND THE DEVICE THEN REPORTED CLUSTER MOTOR AB AS "WARM". WITHIN 5 SECONDS THE DEVICE REPORTED CLUSTER MOTOR AB AS "HOT", AND INITIATED AN AUTO-TRANSITION TO 4-WHEEL DUE TO A MOTOR HOT CONDITION. TWO SECONDS LATER THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION BECAUSE IT EXCEEDED ITS PITCH LIMIT. NO OTHER ALARMS WERE PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BLACK BOX DATA SHOWS THAT DURING THE EVENT, THE CLUSTER POSITION WAS FIXED, REGARDLESS OF CONTROLLER COMMAND AND COMPARABLE MOTOR CURRENT. THE CLUSTER DRIVE AND MOTOR TEMPERATURE STEADILY ROSE AS THE OPERATOR ATTEMPTED TO MOVE THE SEAT (HEIGHT) AND CLUSTER (FRAME LEAN). THE MOTOR TEMP EXCEEDED THE THRESHOLD FOR BALANCE AND TRIGGERED THE AUTO-TRANSITION. THE MECHANICAL MOVEMENT OF AUTO-TRANSITION ROLLS THE WHEELS BACKWARD TO HOLD POSITION WHILE THE CLUSTER ROTATES THE FRONT WHEELS DOWN TO THE GROUND. WITH THE CLUSTER POSITION CONSTRAINED TO THE CHASSIS, THIS NORMAL WHEEL MOVEMENT CAUSED THE DEVICE TO PITCH FORWARD AND RESULT IN THE CONTROLLER FAILURE. IN CONCLUSION, THE DEVICE DID NOT MALFUNCTION, AND BEHAVED AS EXPECTED. EXTERNAL ENVIRONMENTAL CONDITIONS CONSTRAINED THE CLUSTER POSITION, CAUSING A MOTOR HOT CONDITION AND PREVENTED THE DEVICE FROM BEING ABLE TO MAINTAIN DYNAMIC STABILIZATION.

    Description of Event or Problem · 1

    USER REPORTED THAT SHE WAS AT A BAR DRINKING WATER AND EXPERIENCED A FORWARD FALL FROM THE DEVICE WHILE ATTEMPTING TO TRANSITION FROM BALANCE TO 4-WHEEL FUNCTION. USER STATES THAT SHE WENT BACKWARDS TO MAKE ROOM FOR THE TRANSITION. WHEN SHE PROCEEDED WITH THE TRANSITION TO 4-WHEEL, SHE STATES A BROKEN RIGHT FRONT LIGHT GOT CAUGHT IN THE MOVING PARTS AND THE DEVICE FELL FORWARD. USER WAS NOT WEARING THE PROVIDED LAP BELT - STATES IT WAS DAMAGED. IT IS NOTED THAT NEITHER OF THESE DAMAGED PARTS WERE REPORTED PRIOR TO THE EVENT. USER STATES SHE FELL FORWARD AHEAD OF THE DEVICE AND THE DEVICE FELL ON TOP OF HER. USER WAS TRANSPORTED BY EMT'S TO THE ER AND X-RAYS WERE TAKEN OF HER INJURED RIGHT LEG. AFTER X-RAYS AND BEING SEEN BY AN ER DOCTOR, USER WAS TAKEN HOME FOR BED REST. IT WAS NOTED THAT THE INJURED LEG WAS NOT PLACED IN A CAST. USER STATED THAT SHE MAY HAVE BROKEN HER RIGHT LEG - TIBIA AND FIBULA. LATER F/U WITH HER PCP DID NOT CONFIRM ANY SUCH INJURY AND USER WAS ADVISED TO AVOID PUTTING ANY WEIGHT ON THE LEG FOR 2 TO 4 WEEKS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEPENDENCE IBOT 4000 MOBILITY SYSTEM STAIR CLIMBING WHEELCHAIR IMK INDEPENDENCE TECHNOLOGY, L.L.C. IBOT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention