BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE OEC 9800

    MDR report key: 906929 · Received September 4, 2007

    Report

    Report Number
    1720753-2007-05080
    Event Type
    Other
    Date Received
    September 4, 2007
    Date of Event
    August 13, 2007
    Report Date
    September 3, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND THE CUSTOMER DID NOT FOLLOW MANUFACTURER'S RECOMMENDATIONS OR NORMAL PRECAUTIONS TO PROTECT SYSTEM FROM BODY SUBSTANCES. PT BLOOD RAN ALL OVER TUBE HOUSING DURING A PROCEDURE AND WAS NOT COVERED PROPERLY TO PREVENT CONTAMINATION. SERVICE REPRESENTATIVE HAD CUSTOMER PULL SYSTEM FROM USE AND CLEAN THE EXTERIOR USING UNIVERSAL BODY SUBSTANCE ISOLATION TECHNIQUES AND RESPONDED TO THE FACILITY, REMOVED TUBE HOUSE COVER AND CLEANED THE SYSTEM USING APPROPRIATE BODY SUBSTANCE ISOLATION PRE-CAUTIONS. ADDITIONALLY, THE HIGH VOLTAGE CABLES WERE CLEANED AND RE-GREASED PER PROCEDURE. CUSTOMER/USER ABUSE/ERROR. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFORMATION WITH RESPECT TO THIS ISSUE. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYSTEM WAS USED DURING A PROCEDURE AND WAS NOT COVERED APPROPRIATELY. BLOOD AND FLUIDS RAN ALL OVER X-RAY TUBE HOUSING AND THE TUBE HOUSING WAS DRIPPING BLOOD AND FLUIDS AFTER THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR