BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3973040 · Received April 29, 2014

    Report

    Report Number
    8022257-2014-00005
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Removal / Correction Number
    Z-0976-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN AN ARCHIVING TASK STOPS AND RESTARTS WITHIN THE SAME SECOND, A SOFTWARE DEFECT IN HORIZON MEDICAL IMAGING WILL CREATE A NON-UNIQUE 'JOB ID' RESULTING IN AN INCORRECT ARCHIVE LOCATION FOR A STUDY. AS A RESULT, WHEN A RADIOLOGIST RETRIEVED A STUDY FROM ARCHIVE, INCORRECT IMAGES WERE DISPLAYED FOR THE REQUESTED STUDY. MCKESSON HAS DETERMINED THAT THE IDENTIFIED SOFTWARE DEFECT IS THE ROOT CAUSE FOR THIS PROBLEM. MCKESSON HAS DEVELOPED A SOFTWARE SOLUTION WHICH WILL BE PROVIDED TO POTENTIALLY AFFECTED USERS TO REDUCE THE RISK OF FUTURE RECURRENCES.

    Description of Event or Problem · 1

    HORIZON MEDICAL IMAGING SYSTEM VERSION 11.5.2. PRESENTED AN INCORRECT STUDY (SET OF IMAGES) TO A RADIOLOGIST AT THE REPORTING SITE. THE RADIOLOGIST SELECTED AN ARCHIVED STUDY COMPROMISED OF AN ULTRASOUND ENDOCRINOLOGY IMAGES AND WAS PRESENTED AN ULTRASOUND IMAGES FOR A DIFFERENT PATIENT INSTEAD. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255542 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM.SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.5.2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK