BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 1069843 · Received June 30, 2008

    Report

    Report Number
    3003508375-2008-00005
    Event Type
    Other
    Date Received
    June 30, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 27, 2008
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO RETRIEVE THE DEVICE ELECTRONIC CONFIGURATION FILE (ECF) FOR ANALYSIS. THE ANALYSIS DETERMINED THAT THE DEVICE ENTERED STAIR FUNCTION. WITHIN 5 SECONDS, A FRAME LEAN STOP WAS RECORDED. FORTY ONE SECONDS LATER, THE DEVICE RECORDED A CONTROLLER ALERT INDICATING CLUSTER SAFETY LOCK (GOING DOWN). ONE SECOND LATER, THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION DUE TO THE PITCH LIMIT BEING EXCEEDED. NO OTHER FAULTS WERE PRESENT IN THE LOGS THAT CONTRIBUTED TO THIS EVENT. THE BLACK BOX DATA FOR THE EVENT SHOWS THE DEVICE COMPLETING THE DESCENT OF ONE STEP SUCCESSFULLY. THE DEVICE IS RELATIVELY IDLE FOR APPROXIMATELY 4 SECONDS, AND THEN FORWARD PITCH INDUCES A 2ND STEP DESCENT. THIS IS CONSISTENT WITH NORMAL STAIR CLIMBING PROCEDURE. THE DEVICE PITCH IS NOT ADEQUATELY CORRECTED BY THE USER'S ASSISTANT. AS THE WHEEL CLUSTER COMPLETES ITS ROTATION, THE DEVICE PITCH IS RELEASED FORWARD, INDUCING THE CLUSTER SAFETY LOCK. THE DEVICE CONTINUED TO PITCH FORWARD UNTIL THE LIMIT WAS REACHED AND THE DEVICE WENT TO CONTROLLER FAILURE. BASED ON THE PRODUCT LOGS, THE PRODUCT DID NOT MALFUNCTION, AND BEHAVED AS EXPECTED. 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. IT IS CONCLUDED THAT THE ASSISTANT DID NOT ADEQUATELY CONTROL THE DEVICE DURING STAIR DESCENT, WHICH LEAD TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    USER REPORTED A FORWARD FALL WITH THE DEVICE WHILE DESCENDING OUTSIDE STEPS. USER STATES THAT HE SUSTAINED AN INJURY THAT REQUIRED MEDICAL ATTENTION, BUT IS OK NOW. USER DECLINED TO PROVIDE FURTHER DETAILS ON THE EXTENT OF INJURY SUSTAINED. EVENT OCCURRED LAST WEEK - EXACT DATE WAS NOT PROVIDED. USER WAS WEARING THE PROVIDED LAP BELT. USER STATES HE WAS BEING ASSISTED BY A (TRAINED) ASSISTANT, WHO WAS ALSO PULLED DOWN, SUSTAINING CONTUSIONS, BUT NO OTHER INJURY. THE CUSTOMER SERVICE CENTER RETRIEVED THE REMOTE SERVICE CODE AND CONFIRMED CONTROLLER FAILURE, STAIR FUNCTION, PITCH LIMIT EXCEEDED. SERVICE IS REQUIRED TO INSPECT DEVICE, CLEAR SERVICE WRENCH AND RETRIEVE THE DEVICE ELECTRONIC CONFIGURATION FILE FOR REVIEW. THIS REPORT IS FILED AS AN ADVERSE EVENT MDR DUE TO NO PRODUCT MALFUNCTION, AND THE USERS RELUCTANCE TO PROVIDE DETAILS ON THE EXTENT OF ANY INJURY SUSTAINED. THIS REPORT CORRESPONDS TO INDEPENDENCE TECHNOLOGY (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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other