BEUDAMED
    FDA Adverse Event Summary report: N

    POWERCHART

    MDR report key: 1628078 · Received February 10, 2010

    Report

    Report Number
    1628078
    Date Received
    February 10, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 10, 2010
    Manufacturer
    CERNER CORP.
    Product Code
    NSX
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WE HAVE A CERNER EMR SYSTEM THAT IS CONNECTED TO A PHILIPS PATIENT MONITORING SYSTEM TO CHART VITAL SIGNS (VS) SEMI-AUTOMATICALLY. THE SYSTEM REQUIRES THE NURSE TO REQUEST THE VS BE DOWNLOADED, VERIFY THE VS AND HAVE THEM POST TO THE PATIENTS CHART. SEVERAL TIMES THE STAFF REPORTS THAT VITAL SIGNS HAVE BEEN DOWNLOADED, VIEWED, APPROVED AND HAVE SUBSEQUENTLY DISAPPEARED FROM THE SYSTEM. CERNER APPARENTLY WAS AWARE OF THE PROBLEM AND INSTALLED A "PATCH" TO FIX IT. THE FREQUENCY OF THE PROBLEM HAD SIGNIFICANTLY DECREASED BUT THE PROBLEM CONTINUES TO PRESENT. THIS IS A COMPLEX PROBLEM AND TROUBLESHOOTING REQUIRES COLLABORATION BETWEEN IN-HOUSE BIOMED, THE HOSPITAL'S CORPORATE IT EMR TEAM, AND THE CERNER TROUBLESHOOTING TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERCHART EMR SYSTEM NSX CERNER CORP. * *
    2 INTELLIVUE LARGE DATABASE SERVER MONITOR, PHYSIOLOGICAL, DATA BASE SERVER MHX PHILIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *