BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGUS SYSTEM

    MDR report key: 5633403 · Received May 5, 2016

    Report

    Report Number
    1125873-2016-00035
    Event Type
    Death
    Date Received
    May 5, 2016
    Date of Event
    April 7, 2016
    Report Date
    May 25, 2016
    Manufacturer
    PHILIPS VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY ENGINEERING. ENGINEERING DETERMINED THAT THE SERVER THAT PROCESSES THE ECARE MANAGER'S SENTRY ALERTS EXPERIENCED A HOSPITAL -EICU NETWORK CONNECTIVITY ISSUE. THE RESULT OF THE NETWORK CONNECTIVITY ISSUE WAS THAT ONE OF ECARE MANAGER'S SERVICES WAS UNABLE TO RECOVER AND THE SENTRY ALERT DID NOT TRIGGER. AS REPORTED INITIALLY, THE PATIENT WAS GRAVELY ILL AND HAD A CMO/DNR ORDER. ECAREMANAGER PROVIDES A SUPPLEMENTAL ALERT, NOT INTENDED TO BE AN ALARM. THE ALARMS WERE FUNCTIONING AT THE PATIENT BEDSIDE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE PATIENT IDENTIFIER AND THE INVESTIGATOR WAS ABLE TO REMOTELY INVESTIGATE. PATIENT DATA WAS QUERIED AS WELL AS ERROR LOGS. INITIAL EVALUATION DID NOT IDENTIFY ANY ALERTS THAT TRIGGERED FOR THIS PATIENT. THE DATA IS STILL BEING ANALYZED AND THEREFORE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO DOCUMENT (AGE AT TIME OF EVENT) AND (SEX). ADDITIONALLY, THE INVESTIGATION WAS COMPLETED AND IS DOCUMENTED WITHIN (ADDITIONAL MANUFACTURER NARRATIVE). DATE THE INFORMATION BECAME AVAILABLE IS UPDATED AS WELL AS TYPE OF REPORT INDICATING FOLLOW UP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE SMART OR SENTRY ALERTS FOR A PATIENT THEY WERE REMOTELY MONITORING. CUSTOMER REPORTED THE PATIENT WAS GRAVELY ILL AND HAD A CMO/DNR ORDER. THE HOSPITAL ICU STAFF AND THE CUSTOMER'S EICU STAFF DISCUSSED THE PATIENT DURING THE SHIFT MEETING. DURING ROUNDS, THE CUSTOMER EICU STAFF DETERMINED THAT THE PATIENT EXPIRED, HOWEVER, THE EICU DID NOT RECEIVE ANY SMART OR SENTRY ALERTS. CUSTOMER SENT THE INFORMATION TO PHILIPS FOR INVESTIGATION. ADDITIONAL INFORMATION FROM THE CUSTOMER: PATIENT WAS UNSTABLE FOR LONG PERIOD OF TIME, CORRECT CARE WAS BEING PROVIDED; THE PATIENT DIED OF SEPSIS; THE SMART ALERT NOT FIRING DID NOT IMPACT THE CARE TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289792 ARGUS SYSTEM ECAREMANAGER 4.0.1 MSX PHILIPS VISICU 865325

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death