BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 736465 · Received July 1, 2006

    Report

    Report Number
    1317307-2006-00009
    Event Type
    Other
    Date Received
    July 1, 2006
    Date of Event
    April 26, 2006
    Report Date
    June 29, 2006
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    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 IMAGES SHOWED ARTIFACTS THAT WERE CLASSIFIED AS FINGERPRINTS. THE PHYSICAL EXAMINATION DID NOT SHOW ANY PHYSICAL DAMAGE TO THE SCREEN. ARTIFACT INVESTIGATION CONDUCTED BY KODAK HAVE SHOWN THAT FINGERPRINT ARTIFACTS ARE CAUSED BY DIRECT CONTACT OF AN UNPROTECTED FINGER/HAND WITH THE SCREEN SURFACE. MANY LOTIONS AND WATERLESS HAND CLEARNERS 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

    ON A CHEST X-RAY THE PHYSICIAN COULD NOT DETERMINE WHETHER THE IMAGE SHOWED PNEUMONIA OR CONTAINED AN ARTIFACT. A SECOND RADIOGRAPH WAS TAKEN AND THE PT DID NOT HAVE PNEUMONIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other