BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 2418271 · Received January 4, 2012

    Report

    Report Number
    3003508375-2011-00005
    Event Type
    Other
    Date Received
    January 4, 2012
    Date of Event
    December 13, 2011
    Report Date
    January 4, 2012
    Manufacturer
    INDEPENDENCE TECHNOLOGY, LLC
    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 ECF REVIEW DETERMINED THAT THE DEVICE ENTERED STAIR FUNCTION AND A FRAME LEAN STOP WAS RECORDED. TWELVE SECONDS LATER THE DEVICE RECORDED A CONTROLLER ALERT INDICATING CLUSTER SAFETY LOCK (WHILE DESCENDING). WITHIN ONE SECOND, THE DEVICE REPORTED GOING TO A CONTROLLER FAILURE (CF) CONDITION BECAUSE OF EXCEEDING ITS PITCH LIMIT. NO OTHER ALARMS WERE PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE DEVICE ENTERED CLUSTER SAFETY LOCK, AND WENT TO CONTROLLER FAILURE DUE TO EXCEEDING ITS PITCH LIMIT. CLUSTER SAFETY LOCK IS THE DEVICE'S DETECTION OF A LOSS OF CONTROL DURING STAIR CLIMBING. THE SERVICE ENGINEER NOTED ON THE ESAR THAT HE DID NOT NOTICE ANY SYMPTOMS OTHER THAN THE CF CODE. THE USER HAS NOT REPORTED ANY RECURRENCE OF THE DESCRIBED EVENT SINCE THE COMPLETION OF THE SERVICE ACTIVITY. THE CSC FOLLOWED UP WITH THE USER REGARDING FOLLOW UP DOCTOR APPOINTMENTS. THE USER STATED THAT HE IS HEALING UP NICELY AND THAT HIS KNEE IS SLIGHTLY SWOLLEN AND IS NOT SURE IF HE WILL BE FOLLOWING UP WITH A DOCTOR IN THE FUTURE. THE CSC ADVISED THE USER TO FOLLOW UP WITH THE COMPANY IF HE DOES - USER AGREED TO DO SO.

    Description of Event or Problem · 1

    USER REPORTED THAT HE SUSTAINED INJURIES TO HEAD, KNEES, SHOULDER, AND A LACERATION TO THE NOSE FOLLOWING A FORWARD FALL IN THE DEVICE WHILE DESCENDING TWO STEPS WITH A TRAINED ASSISTANT. USER STATES THAT HE WAS AT A GRADUATION PARTY AND WHEN LEAVING, HE HAD TO DESCEND TWO STEPS IN THE DEVICE. USER STATES THAT WHEN HE STARTED TO GO DOWN THE FIRST STEP THE DEVICE MADE AN UNUSUAL NOISE AND PITCHED FORWARD "THROWING" THE USER OUT OF THE DEVICE. THE USER WAS NOT WEARING THE PROVIDED LAP BELT AT THE TIME OF THE EVENT AND LANDED ON A CEMENT SLAB, FOLLOWED BY THE DEVICE. USER WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY ROOM. MEDICAL PERSONNEL AT THE EMERGENCY ROOM ADVISED THE USER TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN AS NECESSARY FOR KNEES, SHOULDERS, HEAD AND FACE INJURY. NO OTHER INJURIES REPORTED. USER REPORTS BEING SORE WITH EDEMA AT INJURY SITES. THE CUSTOMER SERVICE CENTER (CSC) NOTED THAT THE USER SUCCESSFULLY NEGOTIATED ASCENDING THE SAME STEPS WHEN ARRIVING TO THE PARTY. (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 Required Intervention