BEUDAMED
    FDA Adverse Event Other Summary report: N

    OEC 9" I.I. 9600/9800 C-ARM X-RAY TUBE DRAPE

    MDR report key: 906975 · Received August 28, 2007

    Report

    Report Number
    1720753-2007-04895
    Event Type
    Other
    Date Received
    August 28, 2007
    Date of Event
    August 8, 2007
    Report Date
    August 27, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTAMINATED STERILE DRAPES WERE REPORTED AND THIS ISSUE IS UNDER INVESTIGATION THROUGH THE OFFICES. THE ISSUE IS CURRENTLY UNDER GOING A FIELD ACTION DETERMINATION AND HAS BEEN PUSHED TO THE QUALITY REVIEW BOARD TO INVESTIGATE AND FIND CAUSATION AND MITIGATION. GROSS CONTAMINATION NOTED PRIOR TO OPENING OR USE. HOSPITAL INSPECTION REVEALED CONTAMINATION PRIOR TO USE. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION. THIS ISSUE OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    THE GE OEC 9" I.I. 9600/9800 C-ARM X-RAY TUBE DRAPE WAS OPENED AND SEVERAL PACKAGES HAD OBVIOUS GROSS PARTICULATE CONTAMINATION IN AN UN-OPENED STERILE DRAPE BAG. CONTAMINATION NOTED DURING HOSPITAL RECEIVING INSPECTION. NO PT EXPOSURE OR INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC 9" I.I. 9600/9800 C-ARM X-RAY TUBE DRAPE STERILE DRAPE X-RAY TUBE KKX GE OEC MEDICAL SYSTEMS INC. ACCESSORY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR