BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 736463 · Received July 1, 2006

    Report

    Report Number
    1317307-2006-00007
    Event Type
    Other
    Date Received
    July 1, 2006
    Date of Event
    February 22, 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 FILED IMAGES AND A PHYSICAL EXAMINATION OF THE SCREEN. THE FLAT FIELD IMAGES WERE PRINTED AT AN EXTREME CONTRAST IN ORDER TO ENHANCE ANY IMAGE ARTIFACTS. THE FLAT FIELD IMAGES SHOWED ARTIFACTS THAT WERE CLASSIFIED AS FINGERPRINTS, WIPE MARKS AND EDGE SPEED LOSS. THE PHYSICAL EXAMINATION DID NOT SHOW ANY PHYSICAL DAMAGE TO THE SCREEN. ARTIFACT INVESTIGATIONS 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 CLEANERS CONTAIN CHEMICALS THAT CAN DAMAGE PHOSPHOR SCREENS. - WIPE MARKS ARE TYPICALLY CAUSED BY DIRECT CONTACT OF A UNPROCTECTED FINGER/HAND WITH THE SCREEN SURFACE. MANY LOTIONS AND WATERLESS HAND CLEANERS CONTAIN CHEMICALS THAT CAN DAMAGE PHOSPHOR SCREENS. - WIPE MARKS ARE TYPICALLY CAUSED BY CLEANING SOLUTIONS THAT CONTAIN DAMAGING CHEMICALS SUCH AS ISOPROPYL ALCOHOL. KODAK RECOMMENDS USING KODAK MIN-R SCREEN CLEANER, KODAK MIN-R SCREEN CLEANER WIPES OR KODAK INTENSIFYING CLEANER AND ANTISTATIC SOLUTION FOR CLEANING SCREENS. - EDGE SPEED LOSS OCCURS WHEN DAMAGING CHEMICALS ARE INTRODUCED TO THE SCREEN SURFACE THROUGH THE EDGES OF THE CASSETTE. THIS USUALLY OCCURS WHEN THE CASSETTE IS DISINFECTED. THE AFFECTED CR SCREEN WAS REMOVED AND REPLACED WITH A NEW CR SCREEN.

    Description of Event or Problem · 1

    A RADIOGRAPH WAS TAKEN AND ALLEGED TO CONTAIN ARTIFACTS THAT DID NOT ALLOW IT TO BE READ PROPERLY. A SECOND RADIOGRAPHY WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR CASSETTE CR RIGID CASSETTE MQB EASTMAN KODAK COMPANY NA 1799

    Patients

    Seq Age Sex Outcome Treatment
    1 Other