BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCOUT

    MDR report key: 2597413 · Received May 30, 2012

    Report

    Report Number
    1919278-2012-00001
    Event Type
    Other
    Date Received
    May 30, 2012
    Date of Event
    April 4, 2012
    Report Date
    May 30, 2012
    Manufacturer
    BURKE, INC.
    Product Code
    ITI
    PMA / PMN Number
    K023961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: USER ERROR. USER SOMEWHAT CONFUSED, BORN IN (B)(6), STATED HE WAS (B)(6). WE ARE WORKING WITH THE DEALER TO CHECK FOR CHAIR DAMAGE. USER CLAIMS HE CAN GET A SHOCK WHEN TOUCHING A PHONE AFTER INCIDENT. UNIT DOUBLE INSULATED. DEALER SAID HE COULD NOT FIND THIS PROBLEM, WE ARE HAVING DEALER RECHECK CHAIR. INVESTIGATION: WE CANNOT RECREATE THE INCIDENT AS DESCRIBED. SEVERAL QUESTIONS - FOR CONTROL TUBE TO COME OUT OF RECEIVER IT HAS TO BE SEVERAL INCHES PAST USABLE POSITION. UNIT IS A SQUARE TUBE DESIGN - SO GRAVITY AND FRICTION HOLD TUBE IN PLACE. YOU CAN PULL THE WHEELCHAIR AROUND WITH 3/4 OF AN INCH OF TUBING ENGAGED. WE CANNOT PUSH TUBE OUT OF RECEIVER BY PUSHING ON CONTROL ALONE. TO REMOVE CONTROL TUBE WE HAD TO LIFT TUBE WITH ONE HAND AND PUSH WITH THE OTHER. UNIT MOVING AT 4-5 MPH. IF CONTROL FALLS AWAY, UNIT STOPS IN 4-5 FEET. WE DROPPED CONTROL UNIT ON HARD SURFACE AND JOYSTICK DID NOT HAVE PRESSURE ON LEVER - SO UNIT DID NOT CONTINUE MOVING, UNIT STOPPED. DROPPING CONTROL TO THE SIDE IT IS LESS LIKELY FOR UNIT LEVER TO STAY ACTIVATED. CONCLUSION: USER ERROR. FAILURE TO WEAR LAP BELT PER MANUAL, FAILURE TO MAINTAIN CHAIR IN PROPER WORKING ORDER PER MANUAL.

    Description of Event or Problem · 1

    IT IS ALLEGED WHILE DRIVING A POWER CHAIR OVER A YEAR OLD, USER LOST CONTROL OF CHAIR. THE ADJUSTABLE JOYSTICK CONTROL MOUNT, A SQUARE TUBE, CAME OUT OF ITS RECEIVER AND FELL TO THE GROUND (DEALER BELIEVES) OR WAS HANGING AT SIDE OF CHAIR (USER STATES). CHAIR SOMEHOW CONTINUED TO MOVE FOR 20 - 30 FEET AS THE JOYSTICK WAS SOMEHOW BEING ACTIVATED BY CONSTANT CONTACT PRESSURE. CHAIR RAN INTO STORM DRAIN AND USER FELL OUT. USER NOT WEARING LAP BELT AS REQUIRED BY MANUAL. JOYSTICK ADJUSTMENT TUBE CLAMP WAS ON CHAIR ORIGINALLY BUT NOT REPLACED WHEN LOST. USER DID NOT DISCONTINUE USE OF CHAIR WHEN CHAIR WAS NOT IN PROPER WORKING ORDER AS REQUIRED BY MANUAL. USER RECEIVED ASSISTANCE TO PUT TUBE BACK IN RECEIVER AND DROVE CHAIR HOME WITH NO PROBLEM. HE HAD A SWOLLEN KNEE AND WAS SENT HOME WITH A PRESCRIPTION FOR MEDICATION. LATER, USER WENT TO DOCTOR, FOUND HE HAD A CONTUSION ON HIS RIGHT KNEE AND WAS GIVEN A SHOT. NEVER ADMITTED TO HOSPITAL. FOR JOYSTICK ADJUSTMENT TUBE TO COME OUT, IT MUST MOVE 10 INCHES PAST NORMAL USE POSITION AND 6 INCHES PAST MAXIMUM USE POSITION. ALSO, THE WIRE TIES THAT HOLD THE CABLE PLACE HAVE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCOUT POWER WHEELCHAIR ITI BURKE, INC. BOSS 4.5

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR