BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 5434794 · Received February 12, 2016

    Report

    Report Number
    8022257-2016-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    April 25, 2014
    Report Date
    February 11, 2016
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE ROOT CAUSE OF THE PROBLEM WAS A SOFTWARE DEFECT. MCKESSON FOUND THAT THE ISSUE CAN ONLY OCCUR UNDER THE FOLLOWING CIRCUMSTANCES: THE PACS CONTAINS STUDIES IN THE LOCAL CACHE STORAGE, AND THE AFFECTED IMAGES/ STUDIES WERE ERRONEOUSLY MOVED OR DELETED BY A USER, OR HAVE BEEN LOST DUE TO AN UNRELATED FAILURE CONDITION (E.G. DUE TO A DEFECTIVE OR CORRUPT HARD DRIVE), AND THE LOST STUDIES HAVE NOT BEEN SYNCHRONIZED WITHIN THE PACS SYSTEM BY MCKESSON SUPPORT WHEN IMAGES FOR A NEW STUDY ARE SUBSEQUENTLY RECEIVED BY PACS, THE SYSTEM MAY INCORRECTLY RE-USE THE DISK LOCATION PREVIOUSLY USED BY A STUDY THAT HAS BEEN AFFECTED BY A PRIOR DATA LOSS CONDITION DESCRIBED ABOVE. AS A RESULT, TWO DATABASE RECORDS FOR TWO DIFFERENT STUDIES MAY INCORRECTLY INDEX THE SAME IMAGING STUDY, LEADING TO INCORRECT IMAGES BEING DISPLAYED FOR ONE OF THE PATIENTS. MCKESSON WILL WORK WITH POTENTIALLY AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO PREVENT THE RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 1

    MCKESSON IDENTIFIED THAT 8 STUDIES WERE MISSING ON THE SHORT TERM STORAGE LOCATION PRIOR TO PERFORMING A DATA MIGRATION. ALL 8 STUDIES WERE PREVIOUSLY REPORTED . 7 OF THESE REPORTED STUDIES WERE DETERMINED TO BE LOST AND ONE STUDY WAS IDENTIFIED AS BEING INDEXED TO AN INCORRECT PATIENT. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92804 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.8

    Patients

    Seq Age Sex Outcome Treatment
    1