BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING 11 WITH VOXAR 4.2/6.2

    MDR report key: 937081 · Received October 31, 2007

    Report

    Report Number
    8022257-2007-00002
    Event Type
    Malfunction
    Date Received
    October 31, 2007
    Date of Event
    May 3, 2007
    Report Date
    October 31, 2007
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY DETERMINED THAT THE REPORTED PROBLEM ALSO OCCURS WITH VOXAR 3D VERSION 4.2 INTEGRATION WITH HMI. BY MAY 23, 2007, ALL AFFECTED CUSTOMERS WERE NOTIFIED OF THE PROBLEM AND ADVISED OF STEPS TO TAKE TO AVOID THE PROBLEM. SOFTWARE UPDATES FOR HORIZON MEDICAL IMAGING 11.0.X WORKSTATIONS USED WITH INTEGRATED VOXAR 3D SOFTWARE V6.2 THAT ELIMINATE THE REPORTED PROBLEM WERE RELEASED ON JULY, 17 2007. SINCE THIS RELEASE DATE, 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

    AN UNSAVED VOXAR 3D VERSION 6.2 SNAPSHOT IN A STUDY THAT IS SWEPT THEN CLOSED MAY BE INADVERTENTLY SAVED IN THE NEXT STUDY THAT OPENED AND CLOSED. THE INCORRECTLY SAVED SNAPSHOT IS ALSO INCORRECTLY IDENTIFIED WITH THE SECOND STUDY'S PATIENT IDENTIFYING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON MEDICAL IMAGING 11 WITH VOXAR 4.2/6.2 PICTURE ARCHIVING AND COMMUNICATION SYS LLZ MCKESSON MEDICAL IMAGING COMPANY HMI11-VOXAR4.2/6.2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR