BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 1047865 · Received May 14, 2008

    Report

    Report Number
    8022257-2008-00001
    Event Type
    Malfunction
    Date Received
    May 14, 2008
    Date of Event
    September 25, 2007
    Report Date
    May 13, 2008
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY ENGINEERING EXAMINATION REVEALED A SITUATION ON HORIZON MEDICAL IMAGING 11.0.X SOFTWARE ON WHICH THE IP LIBRARY HAS A REFRESH ERROR CAUSING ANNOTATION(S) MOVING IN THE VIEWPORT. THIS ERROR OCCURS ON AN IMAGE THAT HAS NON SQUARE PIXELS AND ANNOTATION(S), AND THE FIRST OPERATION APPLIED TO THAT IMAGE AFTER APPLYING A CUSTOM DISPLAY PROTOCOL IS ADJUST WINDOW/LEVEL. THE MCKESSON AFFECTED PRODUCTS ARE HORIZON RAD STATION ADVANCED OR HORIZON RAD STATION DISTRIBUTED VERSIONS 11.0.3 THROUGH 11.0.8 THAT IS PART OF HORIZON MEDICAL IMAGING 11.0.3 THROUGH 11.0.8 WORKSTATIONS. SOFTWARE UPDATES FOR HORIZON MEDICAL IMAGING 11.0.X WORKSTATIONS THAT ELIMINATE THE REPORTED PROBLEM WERE RELEASED IN 2008. SINCE THIS RELEASE DATE, ALL THE CLINICAL SITES WITH THE ABOVE LISTED PROGRAMS HAVE BEEN IN PROCESS OF BEING UPDATED WITH THE ABOVE LISTED PROGRAM UPDATES.

    Description of Event or Problem · 1

    THE ANNOTATIONS FOUND ON AN IMAGE WITH NON SQUARE PIXELS ARE SLIGHTLY MOVED IF THE FIRST OPERATION APPLIED TO THAT IMAGE AFTER APPLYING A CUSTOMER DISPLAY PROTOCOL IS ADJUST WINDOW/LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMMUNICATION SYS LLZ MCKESSON MEDICAL IMAGING COMPANY HMI11.0.X

    Patients

    Seq Age Sex Outcome Treatment
    1