BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 1047320 · Received May 13, 2008

    Report

    Report Number
    8022257-2008-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    December 31, 2007
    Report Date
    May 13, 2008
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LMB
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY ENGINEERING EXAMINATION REVEALED A RARE SITUATION ON HORIZON MEDICAL IMAGING 11.0.X SOFTWARE WITH HIERARCHICAL STORAGE MANAGEMENT ON WHICH TWO STUDIES SHARE THE SAME DESTINATION LOCATION, BAG AND SERIES. THE PROBLEM WAS CAUSED BY A HUMAN ERROR IN CONFIGURING THE ARCHIVE CONFIGURATION FILE MAKING TWO DEVICES SHARE THE SAME DESTINATION LOCATION. THE MCKESSON PRODUCTS THAT COULD BE AFFECTED ARE THE FOLLOWING HORIZON MEDICAL IMAGING VERSION: WITH HIERARCHICAL STORAGE MANAGEMENT (HSM). SINCE 2008, MCKESSON CUSTOMER SUPPORT HAS BEEN EXAMINING CUSTOMERS SITE'S CONFIGURATION SETTINGS AND, IF MISCONFIGURATION IS DETECTED, REVISING THEM TO ELIMINATE THE PROBLEM.

    Description of Event or Problem · 1

    WHEN ACCESSING MEDICAL IMAGES FOR A PARTICULAR PT, IMAGES FOR A DIFFERENT PT WERE DISPLAYED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1