BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER'S MILLENIUM I & O2G

    MDR report key: 1547765 · Received November 19, 2009

    Report

    Report Number
    1931259-2009-00010
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Date of Event
    November 4, 2009
    Report Date
    November 18, 2009
    Manufacturer
    CERNER CORP.
    Product Code
    LNX
    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 (B)(4), 2009, TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND A SOFTWARE MODIFICATION HAS BEEN DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION CONSIDERS THIS ISSUE TO BE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.

    Description of Event or Problem · 1

    THE ISSUE INVOLVES CERNER MILLENNIUM I&O2G AND AFFECTS USERS THAT UTILIZE THE INTAKE AND OUTPUT SECOND GENERATION TO RECORD A PT'S FLUID INTAKE AND OUTPUT FOR AN SPECIFIED TIME PERIOD. IN CERNER MILLENNIUM, WHEN THE USER INITIALLY LOADS OR REFRESHES THE VIEW IN REVERSE CHRONOLOGICAL ORDER I&O RESULTS DO NOT DISPLAY IN THE TIME COLUMN DIRECTLY AFTER THE SHIFT TOTAL COLUMN. PT CARE COULD BE ADVERSELY AFFECTED, AS CLINICIAN'S FINDINGS MAY BE INACCURATE OR INCOMPLETE. THIS ISSUE COULD RESULT IN SERIOUS INJURY AS CLINICAL DECISIONS COULD BE BASED ON INCOMPLETE DATA. 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
    1 CERNER'S MILLENIUM I & O2G SOFTWARE LNX CERNER CORP. 2007.19 SP2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1