BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR 500 FLEXIBLE SCREEN

    MDR report key: 576659 · Received February 28, 2005

    Report

    Report Number
    1317307-2005-00002
    Event Type
    Other
    Date Received
    February 28, 2005
    Date of Event
    January 18, 2005
    Report Date
    February 25, 2005
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A COMPUTED RADIOGRAPHY (CR) 500 SCREEN ATRIFACT WAS REPORTED BY THE CUSTOMER SITE TO RESEMBLE A SHADOW OR SPOT ON THE LUNG. THE DIAGNOSIS WAS REVISED BY THE RADILOGIST ONCE VIEWING A SECOND IMAGE TO SHOW THE SAME SPOT OR SHADOW IN THE SAME LOCATION AS THE FIRST IMAGE. THERE WERE NOT ANY REPORTS OF PT INJURY OR TREATMENT INITIATED AS A RESULT OF THE INITIAL DIAGNOSIS. KODAK HAS REVIEWED THE CLINICAL AND FLAT FIELD IMAGES FROM THIS CUSTOMER SITE. THE TYPE OF ARTIFACT RESEMBLES AN IRREGULAR SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR 500 FLEXIBLE SCREEN CR STORAGE PHOSPHOR SCREEN MQB EASTMAN KODAK COMPANY NA 1837

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other