BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 2483433 · Received March 1, 2012

    Report

    Report Number
    3003508375-2012-00001
    Event Type
    Other
    Date Received
    March 1, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 1, 2012
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Removal / Correction Number
    NOT APPLICABLE
    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 ENGINEERING REVIEW OF THE ECF DETERMINED THAT ON (B)(6) 2012 AT 13:45:45 GMT, THE DEVICE ENTERED STAIR FUNCTION AND RECORDED A FRAME LEAN STOP. TWENTY SIX (26) SECONDS LATER, THE DEVICE RECORDED A CONTROLLER ALERT INDICATING A CLUSTER SAFETY LOCK CONDITION WHILE DESCENDING. AT THE SAME TIME STAMP, THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION BECAUSE OF EXCEEDING ITS PITCH LIMIT. NO OTHER ALARMS WERE PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE BLACK BOX DATA FOR THE EVENT SHOWS THAT A ONE STEP DESCENT WAS SUCCESSFULLY COMPLETED WITH PROPER CONTROL. A SECOND STEP IS DESCENDED WITH INADEQUATE PITCH CORRECTION BY THE USER, ALLOWING FOR A RAPID FORWARD PITCH OF THE DEVICE AND CLUSTER SAFETY LOCK CONDITION. THE DEVICE THEN CONTINUED TO PITCH FORWARD UNTIL THE LIMIT W AS EXCEEDED. THE CONCLUSION IS THAT THE DEVICE DID NOT MALFUNCTION. THE DEVICE ENTERED CLUSTER SAFETY LOCK, AND WENT TO CONTROLLER FAILURE DUE TO EXCEEDING ITS PITCH LIMIT. CLUSTER SAFETY LOCK IS THE DEVICES DETECTION OF A LOSS OF CONTROL DURING STAIR CLIMBING AND IS CONSISTENT WITH THE USER'S REPORT OF THE CIRCUMSTANCES OF THE EVENT.

    Description of Event or Problem · 1

    USER REPORTED A FORWARD FALL OF THE DEVICE WHILE ATTEMPTING TO DESCEND A SET OF EXTERIOR CEMENT STAIRS IN STAIR FUNCTION. NO INJURY WAS REPORTED. USER STATES THAT HE HAD A PREVIOUS INJURY (PULLED MUSCLE IN ARM) AND WHILE HOLDING ONTO THE RAILING TO DESCEND STEPS, BECAUSE OF HIS ARM INJURY, HE WAS UNABLE TO LEAN BACK PROPERLY/ENOUGH TO KEEP THE DEVICE FROM ROTATING ITS WHEEL CLUSTER, AND THE CHAIR MOVED OUT FROM UNDERNEATH HIM AND PROCEEDED TO DESCEND THE STAIRS ON ITS OWN. THE DEVICE FELL TO THE GROUND, WHILE USER WAS STILL HOLDING ONTO THE RAILING. USER STATES THAT THE DEVICE SUSTAINED NO DAMAGE, OTHER THAN A SCUFF MARK ON THE BACK OF THE ARMREST. USER WAS NOT INJURED, AND HE HAD ASSISTANCE GETTING BACK INTO AND USING THE DEVICE. USER WAS ADVISED BY SERVICE HOTLINE THAT THE EVENT MAY HAVE OCCURRED QUICKLY AND NOT ALLOWED PROPER EXIT FROM CLUSTER SAFETY LOCK, BUT ALSO THAT THE DRIVER/ASSISTANT SHOULD HAVE CONTROL OF THE DEVICE WHILE IN STAIR FUNCTION. IT WAS SUGGESTED TO THE USER TO PERHAPS HAVE ASSISTANCE WITH STAIR CLIMBING WHILE INJURED. FIELD SERVICE WAS DISPATCHED TO INSPECT THE DEVICE, CLEAR THE SERVICE WRENCH AND RETRIEVE THE ELECTRONIC CONFIGURATION FILE (ECF) FOR REVIEW. (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 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other