BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 736446 · Received July 1, 2006

    Report

    Report Number
    1317307-2006-00006
    Event Type
    Other
    Date Received
    July 1, 2006
    Date of Event
    January 18, 2006
    Report Date
    June 29, 2006
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    IXA
    PMA / PMN Number
    K925997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KODAK RECEIVED THE SCREEN AND CASSETTE FOR EVALUATION. OUR EVALUATION INCLUDED CREATING AND PRINTING FLAT FIELD IMAGES AND A PHYSICAL EXAMINATION OF THE SCREEN. THE FLAT FIELD IMAGES WERE PRINTED AT AN EXTREME CONTRAST IN ORDER TO EHANCE ANY IMAGE ARTIFACTS. THE FLAT FIELD IMAGE SHOWED ARTIFACTS THAT WERE CLASSIFIED AS FINGERPRINT ARTIFACTS. THESE WERE LOCATED AT THE EDGES AND CORNERS OF THE IMAGE. THE PHYSICAL EXAMINATION SHOWED AN AREA WITH A SMALL ABRASION AT THE BOTTOM OF THE SCREEN. IN THE FLAT FIELD IMAGE THIS LOOKED LIKE A FOREIGN BODY. THE FINGERPRINT ARTIFACTS HAVE BEEN SEEN ON OTHER CR IMAGES AND ARE ASSOCIATED WITH HANDLING OF THE SCREENS BY BARE HANDS. MANY LOTIONS AND WATERLESS HAND CLEANERS CONTAIN CHEMICALS THAT CAN DAMAGE PHOSPHOR SCREENS. THE AFFECTED CR SCREEN WAS REMOVED AND REPLACED WITH A NEW CR SCREEN.

    Description of Event or Problem · 1

    A RADIOGRAPH TAKEN FOR A TRAUMA CASE SHOWED A FOREIGN BODY. ADDITIONAL RADIOGRAPHS WERE TAKEN TO LOCATE THE FOREIGN BODY AND THESE SHOWED NO FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR CASSETTE CR RIGID CASSETTE IXA EASTMAN KODAK COMPANY NA 1814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other