BEUDAMED
    FDA Adverse Event Summary report: N

    MILLENIUM

    MDR report key: 3020754 · Received March 18, 2013

    Report

    Report Number
    MW5029449
    Date Received
    March 18, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CERNER CORP
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CERNER MILLENNIUM POWER CHART FAILS TO TRACK LIFE CRITICAL IMPLANTED DEVICES SUCH AS PACEMAKERS, WHOSE BATTERIES HAVE FINITE LIFE. THIS PT WAS HOSPITALIZED FOR TWO WEEKS WITH CERNER EHR AND CPOE SYSTEMS DEPLOYED FOR THE CARE. AT NO POINT WAS THERE A WARNING THAT THE BATTERY WAS AT END OF LIFE. AFTER THE PT WAS DISCHARGED FROM THAT HOSPITAL AND THE CARE MANAGED WITH PAPER RECORDS WAS IT NOTED BY AN ASTUTE PHYSICIAN THAT THE PULSE GENERATOR MUST BE URGENTLY REPLACED, THE CERNER SYSTEM FAILS THE PT'S WITH PACEMAKERS BECAUSE IT HAS NO FUNCTIONALITY FOR TRACKING THE LIFE OF THE BATTERY OR ITS IMPLANT DATE. IT IS URGED THAT THERE BE A WARNING ON THE SYSTEM THAT THE EHR DOES NOT RECORD PACEMAKER OR AICD DEFIBRILLATOR SPECIFIC TRACKING INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111842 MILLENIUM POWERCHART CPOE OUG CERNER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| O