BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 2013074 · Received March 1, 2011

    Report

    Report Number
    3003508375-2011-00001
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 1, 2011
    Manufacturer
    INDEPENDENCE TECHNOLOGY, LLC
    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 EVALUATION, 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 ECF WAS NOT RETRIEVED UNTIL (B)(6) 2011 DUE TO A DELAY BY THE USER IN MAKING THE DEVICE AVAILABLE FOR INSPECTION. THEREFORE, ONLY ALARM LOG AND BLACK BOX DATA WAS AVAILABLE FOR REVIEW, AS THE EVENT LOGS HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE DEVICE. ENGINEERING REVIEW OF THE ECR DETERMINED THAT THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION DUE TO THE BALANCE METRIC EXCEEDING ITS LIMIT, WHILE IN 4-WHEEL FUNCTION. THE BLACK BOX DATA CONFIRMS THE DEVICE WAS ON A FLAT LEVEL SURFACE AND DRIVEN FORWARD OVER AN OBSTACLE OR STEP IN 4-WHEEL FUNCTION. AS THE CLUSTER ANGLE LEVELED, IT OVER-ROTATED AS BOTH WHEEL MOTORS SPUN UP INDICATING LOSS OF TRACTION. AT THIS TIME, THE DEVICE WENT TO CONTROLLER FAILURE DUE TO EXCEEDING THE BALANCE METRIC IN 4-WHEEL FUNCTION. THE ECF IS CONSISTENT WITH THE REPORT OF LOSS OF TRACTION DURING A STEP ASCENT IN 4-WHEEL FUNCTION. THE DEVICE WENT TO FAILSAFE AND STOPPED LOGGING DATA PRIOR TO THE DEVICE FALLING BACKWARD AS REPORTED BY THE USER. AT THE TIME OF THE FAILSAFE, THE DEVICE WAS PITCHED FORWARD AND TIPPED FORWARD ONTO THE FRONT TWO WHEELS. IT WAS CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION AND BEHAVED AS EXPECTED. THE DEVICE WENT TO FAILSAFE WHEN CONDITIONS BECAME TOO DYNAMIC TO MAINTAIN STABILITY IN 4-WHEEL FUNCTION.

    Description of Event or Problem · 1

    USER REPORTED A BACKWARDS FALL IN HER DEVICE WHILE OPERATING IN 4-WHEEL FUNCTION ON (B)(6) 2011. USER STATES THAT SHE WAS CLIMBING A CONCRETE STEP FROM A BALCONY INTO HER APARTMENT. USER STATES THAT THE DEVICE SUCCESSFULLY CLIMBED THE STEP, BUT THEN FELL BACKWARDS ON THE CONCRETE BALCONY WHEN THE WHEELS SLIPPED ON THE STEP THAT WAS WET FROM RAIN. USER STATES THAT, BASED ON A FRIENDS DIAGNOSIS, SHE BELIEVES THAT SHE SUSTAINED WHIPLASH AND A CONCUSSION, ALTHOUGH NO ATTENTION WAS SOUGHT FROM A MEDICAL PROFESSIONAL. THE CSC ATTEMPTED TO TROUBLESHOOT THE EVENT WITH THE USER BY REMOTELY RETRIEVING THE SERVICE CODE FROM THE DEVICE. HOWEVER, THE USER WAS NOT WITH THE DEVICE AT THE TIME OF THE CALL, THEREFORE, AN ON-SITE SERVICE VISIT WAS SET UP FOR THE SERVICE ENGINEER TO INSPECT THE DEVICE, RETRIEVE THE ELECTRONIC CONFIGURATION FILE (ECF) FOR REVIEW, AND CLEAR THE SERVICE WRENCH. THIS MDR IS FILED BASED ON THE USER'S UNCONFIRMED ALLEGATION OF INJURY. (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, LLC IBOT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other