BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGUS SYSTEM

    MDR report key: 5417677 · Received February 8, 2016

    Report

    Report Number
    1125873-2016-00001
    Event Type
    Death
    Date Received
    February 8, 2016
    Date of Event
    January 12, 2016
    Report Date
    April 26, 2016
    Manufacturer
    PHILIPS VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INVESTIGATED THE PATIENT DATA IN ECAREMANAGER. ENGINEERING DETERMINED THAT THE USER HAD ADMITTED THAT PATIENT INTO ECAREMANAGER TWO TIMES, ONCE ON (B)(6) 2016 AND ONCE ON (B)(6) 2016. THIS RESULTED IN TWO DIFFERENT CACHE IDS CAUSING THE DATA INTEGRATION ISSUE (MESSAGES WERE ERRORING OUT). THE CUSTOMER WAS CONSULTED AND REQUESTED THE CACHE ASSOCIATED WITH THE (B)(6) 2016 ADMISSION DATE BE CLEARED FROM THE SYSTEM. ENGINEERING COMPLETED THIS TASK AND THE PATIENT DATA STARTED POPULATING AGAIN. LATER THAT SAME DAY, CUSTOMER SUPPORT CALLED THE CUSTOMER TO CONFIRM THAT THE PATIENT DATA WAS POPULATING. THE CUSTOMER INFORMED CUSTOMER SUPPORT THAT THE PATIENT HAD EXPIRED. THERE WAS NO ALLEGATION THAT THE DEVICE HAD CONTRIBUTED TO THE PATIENT'S DEATH. THIS REPORT IS BEING FILED AS THE ECAREMANAGER WAS USED DURING AN EVENT THAT WAS FOLLOWED BY A PATIENT'S DEATH. THE DEVICE FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ECAREMANAGER IS SUPPLEMENTAL TO THE BEDSIDE STAFF AND MONITORING SYSTEMS. THE BEDSIDE MONITORING SYSTEMS WERE AVAILABLE. THE CUSTOMER STATED THAT THE LACK OF TRENDING LABS DID NOT EFFECT PATIENT OUTCOME. THE CUSTOMER STATED THAT THE PATIENT WAS VERY ILL AND THE FAMILY HAD DECIDED TO WITHDRAW SUPPORT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT LAB AND FLOWSHEET ARE NOT TRENDING IN ECAREMANAGER. THE USER STATED THAT SHE CHECKED THE PATIENT ACCOUNT NUMBER AND ALSO REIMPORTED THE PATIENT. AFTER THE ISSUE WAS RESOLVED, THE USER STATED THAT THE PATIENT HAD EXPIRED. THE USER DID NOT IMPLY THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO DOCUMENT FURTHER INFORMATION REGARDING THE EVENT. THE CUSTOMER STATED THAT THE LACK OF TRENDING LABS DID NOT EFFECT PATIENT OUTCOME. THE CUSTOMER STATED THAT THE PATIENT WAS VERY ILL AND THE FAMILY HAD DECIDED TO WITHDRAW SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75883 ARGUS SYSTEM ECARE MANAGER V.4.0.1 MSX PHILIPS VISICU 865325 V4.0.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death