BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOGRAPHY FILM PROCESSOR

    MDR report key: 33819 · Received May 24, 1996

    Report

    Report Number
    MW4001374
    Event Type
    Malfunction
    Date Received
    May 24, 1996
    Report Date
    December 12, 1994
    Manufacturer
    EASTMAN KODAK CO.
    Product Code
    IXW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO PROCESS MAMMOGRAPHY X-RAY FILMS DUE TO POOR DESIGN. THE PROCESSOR IN QUESTION WAS INSTALLED IN 6/94, SINCE THEN NUMEROUS PROBLEMS HAVE OCCURRED. A DISTINCT FLAME PATTERN ON FILM WAS FROM A POOR DESIGN IN THE DEVELOPER RECIRCULATION SYSTEM. ROLLER MARKS WERE BEING LEFT ON FILMS FROM POORLY DESIGNED DEVELOPER ROLERS AND CROSSOVER RACKS WHICH MADE RADIOGRAPHS UNACCEPTABLE BY ACR. DEFECTIVE TEMP CONTROL MICROPROCESSOR BOARD RENDERED THE PROCESSOR UNABLE TO PROCESS MAMMOGRAPHY FILMS. THE LAST PROBLEM THAT WAS ENCOUNTERED WAS AN ICICLE PATTERN ON THE FILM THAT COULD NOT CORRECT, AND WAS CAUSED BY THE FAULTY RACK SYSTEM. SINCE THIS UNIT WAS INSTALLED IN 6/94 THIS UNIT HAS YET TO PROCESS AN ACCEPTABLE X-RAY FILM. CO SVC AND REPAIR PERSONNEL HAVE MADE NUMEROUS ATTEMPTS TO REPAIR THIS UNIT WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOGRAPHY FILM PROCESSOR MAMMOGRAPHY FILM PROCESSOR IXW EASTMAN KODAK CO. M35A-M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA