BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 4189342 · Received October 16, 2014

    Report

    Report Number
    8022257-2014-00013
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON INVESTIGATED THE ROOT CAUSE OF THIS ISSUE AND DETERMINED THAT THE DELAY IN RETRIEVING THE PRIOR STUDY FROM ARCHIVE IS DUE TO A UNIQUE SCENARIO WITH THE SOFTWARE CONFIGURATION APPLIED TO A PRE-EXISTING CUSTOMER NETWORK INFRASTRUCTURE. MCKESSON PROVIDED A CONFIGURATION CHANGE TO THE AFFECTED SITE TO PREVENT THE PROBLEM FROM OCCURRING. MCKESSON ARE DEVELOPING A SOFTWARE UPDATE TO OPTIMIZE SYSTEM PERFORMANCE IN THE REPORTING FACILITY'S ENVIRONMENT, AND PREVENT FUTURE RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT AN ARCHIVED PRIOR STUDY WAS UNAVAILABLE FOR AN ANESTHETIZED PT DURING SURGERY. IT WAS ALLEGED THAT THE SURGERY WAS DELAYED FOR APPROX 20 MINUTES AS A RESULT. NO PT HARM WAS REPORTED DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656614 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM.SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK