BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 5809958 · Received July 20, 2016

    Report

    Report Number
    8022257-2016-00002
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 22, 2016
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K140909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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 STAT PRIORITY ALERT ICON MAY NOT BE DISPLAYED IN THE LIST, FOR ANY USER, WHEN ALL STAT STUDIES ARE OPENED AT THE SAME TIME AND THERE ARE NO "HIGH" PRIORITY STUDIES IN THE UNREPORTED STUDY LIST. UNDER THESE CONDITIONS, THE STAT PRIORITY BUTTON WILL NOT DISPLAY THE CORRECT NUMBER OF STAT STUDIES. MCKESSON WILL WORK WITH AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO PREVENT THE RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STAT PRIORITY ICON WAS NOT DISPLAYED IN THE STUDY LIST WHEN THE STUDY WAS OPENED. NO PATIENT HARM WAS REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464238 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1