BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER MILLENNIUM POWERCHART, POWERNOTE, FIRSTNET, SURGICAL POWERCHART, INET, TH

    MDR report key: 3810088 · Received April 9, 2014

    Report

    Report Number
    1931259-2014-00004
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CERNER CORP.
    Product Code
    OUG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION ON APRIL 4, 2014 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, A SCRIPT TO PREVENT THE ISSUE IN THE INTERIM AND 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 MODIFICATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE ISSUE INVOLVES CERNER MILLENNIUM POWERCHART, POWERNOTE, FIRSTNET, SURGICAL POWERCHART, INET, THE CLINICAL VIEWER, CVNET, OR CARE MANAGER AND AFFECTS USERS THAT UTILIZE THE DOCUMENT VIEWING TAB TO VIEW OR ADD CLINICAL NOTES ON A PT'S CHART. THE ISSUE MAY OCCUR WHEN THE USER HAS SET THEIR DEFAULT TAB TO A TAB OTHER THAN DOCUMENT VIEWING IN THE TOC. WHEN A PT'S CHART IS DISPLAYED AND THE USER THEN NAVIGATES TO ANOTHER PT'S CHART THEN RETURNS TO THE ORIGINAL PT CHART, A LIST OF NOTES FOR A PT OTHER THAN THE PT DISPLAYED IN THE DEMOGRAPHICS BAR MAY BE DISPLAYED IN THE DOCUMENT VIEWING TAB, AND YOU MAY CREATE NOTES FOR A PT OTHER THAN THE PT DISPLAYED IN THE DEMOGRAPHICS BAR IN THAT TAB. PT CARE COULD BE ADVERSELY AFFECTED IF CLINICAL DECISIONS ARE MADE BASED ON WRONG PT INFO OR IF INCORRECT CAUSES A DELAY IN CARE. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PT EVENTS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213659 CERNER MILLENNIUM POWERCHART, POWERNOTE, FIRSTNET, SURGICAL POWERCHART, INET, TH SOFTWARE OUG CERNER CORP. 2012.01.22-28 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other