BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 826934 · Received March 9, 2007

    Report

    Report Number
    3003508375-2007-00002
    Event Type
    Other
    Date Received
    March 9, 2007
    Date of Event
    February 13, 2007
    Report Date
    March 8, 2007
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO INSPECT THE DEVICE, CLEAR THE SERVICE WRENCH AND RETRIEVE THE ECF LOG FILE FOR ANALYSIS. A REPORT ON FIELD SERVICE ACTIVITY (SAR) AND A DEVICE CHECKOUT RECORD (FCR) WAS FORWARDED TO THE COMPLAINT HANDLING UNIT (CHU) PER SOP. LOG FILE REVIEW DETERMINED THE DEVICE ENTERED CLUSTER SAFETY LOCK (GOING DOWN STAIRS) AND THAT, AT THE SAME TIME, IT'S PITCH LIMIT WAS EXCEEDED. THIS IS CONSISTENT WITH THE ASSISTANTS DESCRIPTION OF THE EVENT. CLUSTER SAFETY LOCK (SCL) IS THE DEVICES DETECTION OF OUT OF CONTROL STAIR CLIMBING, AND PER USER TRAINING, REQUIRES THE USER/ASSISTANT TO RESPOND APPROPRIATELY TO CORRECT THE CONDITION(S) CAUSING THE CSL. THIS DID NOT OCCUR IN THIS CASE, LEADING TO THE EVENT AS REPORTED. FOLLOW UP WITH THE USER'S ASSISTANT INDICATED THAT "SHE PROBABLY JUST LOST FOCUS FOR A MINUTE AND DIDN'T PUSH DOWN ON THE ASSIST HANDLE TO SLOW THE ROTATION". THIS IS PART OF THE TRAINED/REQUIRED TECHNIQUE FOR ASSISTED STAIR CLIMBING. FAILURE TO PERFORM THE TECHNIQUE CORRECTLY CAN LEAD TO THE REPORTED EVENT. THE COMPANY OFFERED ADDITIONAL STAIR TRAINING TO BOTH PARTIES, WHICH WAS DECLINED. BOTH PARTIES UNDERSTAND THAT THEY CAN CONTACT THE COMPANY AT ANY TIME FOR ADDITIONAL ASSISTANCE OR TRAINING. THE USER HAS NOT REPORTED ANY RECURRENCE OF THE DESCRIBED EVENT SINCE THE COMPLETION OF THE SERVICE ACTIVITY. IT WAS ALSO REPORTED THAT BOTH PARTIES HAVE RESUMED STAIR CLIMBING ACTIVITIES WITHOUT INCIDENT. NO PRODUCT MALFUNCTION OCCURRED, AND THE DEVICE PERFORMED AS EXPECTED FOR THE GIVEN CONTROL INPUTS.

    Description of Event or Problem · 1

    USER'S ASSISTANT (MOTHER) REPORTED A FALL DURING ASSISTED STAIR CLIMBING. CALLER STATED THAT THEY GOT GOING TOO FAST DOWN STEPS AND DEVICE WENT FORWARD AND HIT THE WALL IN FRONT OF HER (STAIR TURNS). THE USER DID NOT FALL FROM THE DEVICE, AS SHE WAS WEARING THE PROVIDED LAP BELT. CONSUMER'S FACE HIT THE WALL AND SHE RECEIVED SOME BRUISING AND SCRATCHES. ASSISTANT ALSO HIT THE WALL AND WAS INJURED WITH A BUMP ON THE HEAD, SOME BRUISING ON HER FACE AND A CUT TO THE LIP. BOTH PARTIES REPORT THEY ARE OK AND DO NOT REQUIRE MEDICAL ATTENTION. DURING A FOLLOW UP TELEPHONE CALL WITH THE USER'S ASSISTANT, ADDITIONAL DETAILS WERE PROVIDED REGARDING THE REPORTED INJURIES. FURTHER INFORMATION ALSO INDICATED THAT INATTENTION TO THE ASSISTED STAIR CLIMBING PROCEDURE MAY HAVE CONTRIBUTED TO THE EVENT. WHILE IT WAS CONFIRMED THAT A DEVICE MALFUNCTION DID NOT OCCUR, THIS REPORT IS FILED DUE TO THE REPORTED INJURIES TO THE USER AND ASSISTANT.

    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 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other