BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLASSIC CR SYSTEM USING VERSION 5.7 SOFTWARE

    MDR report key: 4122464 · Received July 31, 2014

    Report

    Report Number
    1317307-2014-00014
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 22, 2014
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    P080018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION, THE ISSUE IS RELATED TO A VERSION 5.7 SOFTWARE DEFECT. THIS ISSUE IS ONLY PRESENT WHEN PRINTING TRUE SIZE MULTIFORMAT MAMMOGRAPHIC IMAGES. AS A RESULT, THE PRINT AREA CHANGES FROM TRUE SIZE TO SCALE TO FIT, WHERE IMAGE MAGNIFICATION IS LESS THEN TRUE SIZE OR 100%. IF THE USER HAS A TEXTBOX PRESENT ON THE IMAGE SHOWING IMAGE MAGNIFICATION THEY WILL BE AWARE OF THE PRINT AREA CHANGE TO SCALE TO FIT, HOWEVER IF THEY CHOOSE TO REMOVE THE TEXT BOX THEY MAY BE UNAWARE THAT THE PRINTED MULTIFORMAT IMAGE IS NOT THE SELECTED TRUE SIZE. THIS ISSUE DOES NOT IMPACT PRINTING ONE MAMMOGRAPHIC TRUE SIZE IMAGE OR AFFECT MAMMOGRAPHIC IMAGES VISUALIZED ON SOFT COPY DISPLAY. ALSO THIS ISSUE DOES NOT AFFECT TRUE SIZE MULTIOFORMAT PRINTING FOR GENERAL RADIOGRAPHY IMAGES.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT WHEN SELECTING TRUE SIZE MULTI-FORMAT PRINTING OF MAMMOGRAPHY IMAGES, THE PRINT AREA CHANGES TO SCALE TO FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449119 CLASSIC CR SYSTEM USING VERSION 5.7 SOFTWARE CLASSIC IZL CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA