BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENIUM

    MDR report key: 2190742 · Received July 31, 2011

    Report

    Report Number
    MW5021576
    Event Type
    Death
    Date Received
    July 31, 2011
    Date of Event
    May 16, 2009
    Report Date
    July 31, 2011
    Manufacturer
    CERNER
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WE HAVE BEEN CONCERNED THAT THE EMR AND ITS INCLUSIVE ELECTRONIC ORDERING AND E-MAR - MEDICATION ADMINISTRATION - CREATES INNUMERABLE IMPEDIMENTS TO SAFE AND EFFICIENT CARE AND COMMUNICATION. IN THIS CASE, AN ANESTHESIOLOGIST HAD TROUBLE PLACING AN ENDOTRACHEAL TUBE DURING AN ELECTIVE INTUBATION FOR A PROCEDURE. THUS, THE PT WAS GIVEN A DIAGNOSIS OF "DIFFICULT INTUBATION." THE PT WAS EXTUBATED AFTER THE PROCEDURE, BUT DEVELOPED RESPIRATORY DISTRESS, WHICH SHOULD HAVE BEEN PREDICTABLE BASED ON CHEST RADIOGRAPH WHICH WAS EITHER NOT LINKED TO THE EMR OR WAS NOT ACCESSED AND EVALUATED BECAUSE THERE WAS NOT ANY NOTIFICATION THAT IT WAS READY FOR VIEWING, NOR WAS THERE ANY NOTIFICATION THAT IT HAD BEEN EVALUATED BY A RADIOLOGIST. WHEN THE NEED TO REINTUBATE THE PT BECAME URGENT, THE ACUTE CARE TEAM WAS NOT AWARE OF THE DIAGNOSIS "DIFFICULT INTUBATION", AND WAS NOT PREPARED FOR THE DIFFICULTY. THE EMR WAS TO HAVE PROVIDED THAT CRITICAL DIAGNOSIS AS A HIGHLIGHTED WARNING AT THE TOP OF THE SCREENS. IT FAILED TO DO SO. THERE WERE NO OTHER WARNINGS. IN THE MAYHEM THAT FOLLOWED DUE TO THE DEFECTIVE EMR AND FAILED COMMUNICATION SO ASSOCIATED, AND THE LACK OF PREPAREDNESS, THE PT SUFFERED RESPIRATORY FAILURE, RESPIRATORY AND CARDIAC ARREST, ANOXIC BRAIN INJURY, AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENIUM CPOE, POWER CHART NSX CERNER

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death