BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 3855610 · Received May 29, 2014

    Report

    Report Number
    3003508375-2014-00001
    Event Type
    Other
    Date Received
    May 29, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 29, 2014
    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 SVC WRENCH. A FIELD SVC ACTIVITY/DEVICE CHECKOUT REPORT (ESAR) WAS FORWARDED TO THE COMPLAINT HANDLING UNIT (CHU) PER STANDARD OPERATING PROCEDURE. THE USER HAS NOT REPORTED ANY RECURRENCE OF THE DESCRIBED EVENT SINCE THE COMPLETION OF THE SVC ACTIVITY. THE ECF REVIEW DETERMINED THAT THE DEVICE ENTERED BALANCE FUNCTION ON (B)(6) 2014, AT 16:06:58 GMT AND WAS OPERATED FOR 3 MINS 25 SECONDS BEFORE RECORDING A CONTROLLER ALERT INDICATING AN AUTO-TRANSITION DUE TO LOSS OF TRACTION. WITHIN 2 SECONDS, THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION BECAUSE THE ROLL LIMIT WAS EXCEEDED. THERE WERE NO OTHER ALARMS PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE BLACK BOX DATA FOR THE EVENT CONFIRMS THAT WHILE DRIVING IN BALANCE FUNCTION THE DEVICE EXPERIENCED A ROLL OF A FEW DEGREES, DURING WHICH BOTH SIDES SHOWED SIGNIFICANT LOSS OF WHEEL TRACTION. THIS INDUCED THE CONTROLLER ALERT AND AUTO-TRANSITION. AS A WHEEL CLUSTERS ROTATED THE TOP WHEELS TO THE GROUND, THE DEVICE ROLLED TO THE SIDE AND THE 60 DEGREES LIMIT WAS EXCEEDED. IN CONCLUSION, THE PRODUCT DID NOT MALFUNCTION AND BEHAVED AS EXPECTED. THE PRODUCT DOES NOT HAVE DYNAMIC LATERAL STABILIZATION. ENVIRONMENTAL AND DYNAMIC DRIVING CONDITIONS BOTH CAN CONTRIBUTE TO THE DEVICE ROLLING LATERALLY. THE DATE IS CONSISTENT WITH THE USER'S REPORT OF THE EVENT.

    Description of Event or Problem · 1

    USER REPORTED A FALL OF AND FROM THE DEVICE WHILE OPERATING OUTSIDE IN BALANCE FUNCTION. USER STATED THAT HE SUSTAINED AN ABRASION TO THE FOREHEAD. USER STATED THAT HE WAS IN BALANCE FUNCTION IN THE YARD AND RAN INTO A STAKE. THE DEVICE AUTO-TRANSITIONED TO 4-WHEEL FUNCTION AND HE FELL OUT OF THE DEVICE ONTO THE GRASS. USER STATED THAT THE DEVICE FELL ON TOP OF HIM. USER STATED THAT HE WAS NOT WEARING THE PROVIDED LAP BELT AT THE TIME OF THE EVENT. USER STATED THAT HE WAS ON HIS STOMACH ON THE GRASS FOR ABOUT 10 MINS BEFORE HE WAS ABLE TO GET SOMEONE'S ATTENTION. AN ATTENDANT WAS ABLE TO LIFT THE DEVICE OFF THE USER AND SUMMON EMS. USER STATED THAT HE WAS NOT INJURED OTHER THAN A SCRAPE ON HIS FOREHEAD AND THAT HE WAS NOT GOING TO SEEK MEDICAL ATTENTION. THE CSC ADVISED THE USER TO TRANSFER OUT OF THE DEVICE AND THEN ASSISTED WITH POWERING THE DEVICE OFF. USER WAS INSTRUCTED NOT TO POWER THE DEVICE BACK ON UNTIL FIELD SVC COULD VISIT TO INSPECT IT. ALTHOUGH NO DEVICE MALFUNCTION IS INDICATED, THIS MDR IS BEING FILED DUE TO THE POTENTIAL FOR INJURY AS A RESULT OF THE UNIQUE SEQUENCE OF EVENTS ASSOCIATED WITH EVENT IF IT WAS TO RECUR. INDEPENDENCE TECHNOLOGY INTERNAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317367 INDEPENDENCE IBOT 4000 MOBILITY SYSTEM STAIR CLIMBING WHEELCHAIR IMK INDEPENDENCE TECHNOLOGY, L.L.C. IBOT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other