BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RAADIOLOGY

    MDR report key: 3807302 · Received March 19, 2014

    Report

    Report Number
    8022257-2014-00002
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MED IMAGING COMPANY COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE ROOT CAUSE OF THE PROBLEM WAS A SOFTWARE DEFECT. IN MCKESSON RADIOLOGY STATION VIEWER, THE RADIOLOGY WORKLIST DISPLAYS A PRIORITY ALERT ICON AS A VISUAL INDICATOR FOR STAT AND HIGH PRIORITY STUDIES. AT THE REPORTED FACILITY, THE RADIOLOGY WORKLIST DID NOT DISPLAY THE PRIORITY ALERT ICON FOR HIGH PRIORITY STUDIES WHENEVER NO STAT PRIORITY STUDIES ARE LISTED IN THE WORKLIST. IF THE USER DID NOT SEE THE HIGH PRIORITY ICON, THE STUDY MAY BE CONSIDERED AS ROUTINE OR LOW PRIORITY AND THAT WOULD CAUSE A POTENTIAL IN DELAY IN CARE FOR THE PTS WHO REQUIRE IMMEDIATE TREATMENT. MCKESSON MEDICAL IMAGING COMPANY CUSTOMER SUPPORT WILL WORK WITH POTENTIALLY AFFECTED CUSTOMERS TO APPLY A SOFTWARE UPDATE TO PREVENT THE RECURRENCE ON THIS PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE FACILITY, THE HIGH PRIORITY ALERT ICON WAS NOT DISPLAYED IN THE RADIOLOGY WORKLIST FOR HIGH PRIORITY STUDIES WHEN THERE ARE NO STAT STUDIES ON THE WORKLIST. HOWEVER, THE PRIORITY ALERT ICON IS VISIBLE WHEN STUDIES MARKED AS STAT PRIORITY EXIST IN THE WORKLIST. NO PT HARM WAS REPORTED DUE TO THIS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163390 MCKESSON RAADIOLOGY LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK