BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGUS SYSTEM

    MDR report key: 4962996 · Received July 31, 2015

    Report

    Report Number
    1125873-2015-00013
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    December 10, 2011
    Report Date
    July 28, 2015
    Manufacturer
    PHILIPS VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DATABASE LOGS WAS USED TO EVALUATE THE SOFTWARE AT THE HEALTH SYSTEM. THE COMPLAINT WAS INVESTIGATED THE DAY IT WAS REPORTED. ONCE THE DATE OF THE EVENT WAS CORRECTED TO BE (B)(6) 2011, THE AVAILABLE SYSTEM LOGS IDENTIFIED THAT THE SOFTWARE BEHAVED ACCORDING TO DESIGN PER THE PREDEFINED HR RULES. THE RULES FOR TRIGGERING AN HR ALERT ARE: 2 CONSECUTIVE 1-MIN HR VALUES > 150 OR 10-MIN HR > 150 OR 2 CONSECUTIVE 1-MIN HR VALUES < 40 OR 10-MIN HR < 40 OR 10-MIN HR VALUE > PT UPPER LIMIT (130) OR 10-MIN HR VALUE < PT LOWER LIMIT (50). THE 5 MINUTE AND 10 MINUTE LOGS INDICATE THAT DEVICE FUNCTIONED AS INTENDED. THE 1 MINUTE LOGS HAD BEEN PURGED OUT OF THE SYSTEM AND USER FACILITY DID NOT PROVIDE THE BACKUP LOGS FOR PHILIPS VISICU TO RESEARCH. THIS REPORT IS BEING FILED AS THE ECARE MANAGER DEVICE WAS USED DURING AN EVENT THAT WAS FOLLOWED BY A PT'S DEATH. ADDITIONAL INFO BECAME KNOWN ON 07/28/2015 DURING A RETROSPECTIVE REVIEW OF COMPLAINTS. PHILIPS VISICU ATTEMPTED TO CONFIRM THE PT'S DEATH WITH USER FACILITY, HOWEVER, THE USER FACILITY WAS UNABLE TO PROVIDE CONFIRMATION. THERE IS NO DATA THAT INDICATES THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING AND TRENDING.

    Description of Event or Problem · 1

    PHILLIPS VISICU IDENTIFIED A REPORTABLE EVENT DURING A RETROSPECTIVE REVIEW OF COMPLAINTS. THE USER FACILITY REPORTED ON 12/13/2011 THAT THE SMART ALERTS IN ECARE MANAGER DID NOT FIRE ON ONE PT AND THEY SHOULD HAVE. THE USER FACILITY STATED THAT THE HR ALERT SHOULD HAVE FIRED AT 7:06 ON (B)(6) 2011. FURTHER INFO PROVIDED STATED THAT THE PT WAS CODING WHEN THE SMART ALERTS SHOULD HAVE GONE OFF. LATER THE USER FACILITY CONFIRMED THAT THE CORRECT DATE OF THE EVENT WAS (B)(6) 2011. ON 07/28/2015 DURING RETROSPECTIVE REVIEW, IT WAS IDENTIFIED THROUGH PHILIPS VISICU'S DATA LOGS THAT THE PT HAD EXPIRED SOMETIME AFTER THE INCIDENT. WE WERE UNABLE TO CONFIRM THE EXACT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499137 ARGUS SYSTEM ECAREMANAGER SOFTWARE (V.3.7.1) MSX PHILIPS VISICU 865325

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death