BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER MILLENNIUM RADNET

    MDR report key: 907109 · Received August 30, 2007

    Report

    Report Number
    1931259-2007-00004
    Event Type
    Malfunction
    Date Received
    August 30, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 29, 2007
    Manufacturer
    CERNER CORP.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER HAS DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION AUGUST 29, 2007 TO ALL POTENTIALLY IMPACTED CLIENT SITES. SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND AN INTERIM WORKFLOW ADJUSTMENT TO PREVENT THE MALFUNCTION. A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE SOFTWARE CORRECTION IS AVAILABLE.

    Description of Event or Problem · 1

    THE ISSUE INVOLVES THE CERNER MILLENNIUM RADNET RADIOLOGY DESKTOP AUTO-LAUNCH STUDY AND AUTO-LAUNCH REPORT FUNCTIONALITIES. WHEN USERS CHANGE PT CONTEXT WHILE A STUDY IS BEING AUTOMATICALLY LAUNCHED, THE SYSTEM COULD DISPLAY IMAGES OR REPORTING OPTIONS FOR THE INCORRECT PT. THE ISSUE COULD POTENTIALLY CAUSE THE RADIOLOGIST TO INTERPRET IMAGES FROM ONE PT AND GENERATE DICTATION ON A DIFFERENT PT. THIS ISSUE MAY BE AVOIDED BY VALIDATION OF PT AND EXAM CONTEXT BETWEEN THE DISPLAY IN RADIOLOGY DESKTOP, THE DIGITAL DICTATION WINDOW AND THE IMAGE HEADERS IN THE VIEWER. CERNER RECEIVED COMMUNICATION THAT THREE RADIOLOGY REPORTS WERE GENERATED IN ASSOCIATION WITH AN INCORRECT IMAGE, HOWEVER, CLINICIANS RECOGNIZED THE DISCREPANCY AND CONTACTED THE RADIOLOGY DEPARTMENT. CERNER HAS RECOMMENDED USERS TURN OFF THE AUTO-LAUNCH STUDY AND AUTO-LAUNCH REPORT FUNCTIONALITIES IF USERS ARE NOT PROCEEDING THROUGH THE WORKLIST IN THE ORDER AUTO-LAUNCH DISPLAYS. NO SERIOUS ADVERSE PT EVENT WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERNER MILLENNIUM RADNET RADIOLOGY DESTOP (RDT) LNX CERNER CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR