BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSPEED VCT

    MDR report key: 2181178 · Received July 21, 2011

    Report

    Report Number
    2126677-2011-00115
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K082761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE FIELD ENGINEER WAS ON SITE AND EVALUATED THE DEVICE AND OPERATIONAL ENVIRONMENT. THE FIELD ENGINEER DISCOVERED THAT AN ECG (ELECTROCARDIOGRAPH) DEVICE WAS IN CLOSE PROXIMITY TO THE GANTRY. THE ECG SIGNAL WIRES WERE BUNDLED IN A BLACK CABLE WRAP THAT IS PROPERLY DRESSED ON THE FLOOR. IT WAS DETERMINED THAT THE EVENT WAS CAUSED BY AN ATTENTION FAILURE ON THE PART OF THE OPERATOR WHICH WAS CONFIRMED BY THE USER FACILITY. THE FACILITY IS RESPONSIBLE FOR STORAGE AND PLACEMENT OF EQUIPMENT WHEN NOT IN USE AND TOOK CARE TO PROPERLY BUNDLE THE CORDS, ALTHOUGH THE OPERATOR STILL TRIPPED. THE DEVICE LABELING WAS REVIEWED AND PROVIDES CAUTIONS AND WARNINGS IN REGARD TO THE SETUP OF THE ECG EQUIPMENT WHEN IN USE IN ORDER TO PREVENT INTERFERENCE WITH THE EXAM AND TO ENSURE PT SAFETY. AS THE EKG UNIT WAS NOT IN USE, THERE IS NO CONCERN FOR PT SAFETY. THE SETUP WAS LOCATED IN THE BACK OF THE GANTRY, THUS THERE WOULD HAVE BEEN NO RISK TO PTS IN THIS SITUATION AS IT IS AWAY FROM A COMMON WALKING PATH FROM THE TABLE TO THE DOOR. THIS IS AN ISOLATED EVENT NOT RELATED TO ANY MALFUNCTION OR DEFICIENCY IN THE DEVICE OR ITS LABELING. THE HOSPITAL HAS TAKEN ACTION TO CHANGE THEIR WORKFLOW TO UNPLUG THE ECG MACHINE AND WRAP THE CORDS WHEN THE UNIT IS NOT IN USE TO AVOID FUTURE INCIDENTS. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    THE OPERATOR REPORTED THAT AS SHE WAS MOVING THE INJECTOR BOOM ON A LIGHTSPEED VCT TO SET THE PT UP FOR A CONTRAST INJECTION, HER FOOT BECAME ENTANGLED IN THE ECG SIGNAL WIRE BUNDLE CAUSING HER TO TRIP. AS A RESULT OF THE INCIDENT, THE OPERATOR'S ANKLE BECAME BLACK AND BLUE AND WAS SWOLLEN. IT WAS DETERMINED BY HER DOCTOR TO BE A GRADE TWO STRAIN OF THE ANKLE. THE OPERATOR RECEIVED A TEMPORARY BOOT ON HER ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED VCT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC 5124069-12

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention