BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 736514 · Received July 1, 2006

    Report

    Report Number
    1317307-2006-00010
    Event Type
    Other
    Date Received
    July 1, 2006
    Date of Event
    April 24, 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 IMAGES SHOWED ARTIFACTS THAT WAS CLASSIFIED AS MOTTLE. THE PHYSICAL EXAMINATION DID NOT SHOW ANY PHYSICAL DAMAGE TO THE SCREEN. ARTIFACT INVESTIGATION CONDUCTED BY KODAK HAVE SHOWN THAT MOTTLE ARTIFACTS IS CAUSED WHEN A SCREEN IS RE-INSERTED INTO A CASSETTE NOT FULLY DRY. THE CLEANING SOLUTION IS THEN ABSORBED BY THE PROTECTIVE FOAM AND, IN CONTACT WITH THE SCREEN SURFACE, WILL CAUSE AN ARTIFACT. THE AFFECTED CR SCREEN WAS REMOVED AND REPLACED WITH A NEW CR SCREEN.

    Description of Event or Problem · 1

    AN ARTIFACT ON A RADIOGRAPH OF THE RIGHT KNEE RESEMBLED A BONE TUMOR DISTAL FEMUR. WHEN READING THE RADIOGRAPH, THE RADIOLOGIST THOUGHT WHAT HE OBSERVED WAS AN ARTIFACT BUT RAN AN ADDITIONAL RADIOGRAPH TO CLARIFY AND CONFIRM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other