BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGUS SYSTEM

    MDR report key: 5021958 · Received August 21, 2015

    Report

    Report Number
    1125873-2015-00015
    Event Type
    Death
    Date Received
    August 21, 2015
    Date of Event
    August 12, 2015
    Report Date
    October 7, 2015
    Manufacturer
    PHILIPS VISICU
    Product Code
    MSX
    PMA / PMN Number
    K001972
    Removal / Correction Number
    1125873-08-06-15-014-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 IS SUBMITTED DUE TO AN ERROR MADE ON FOLLOW UP #1. A FIELD ACTION NUMBER WAS PROVIDED; HOWEVER, THERE IS NO FIELD ACTION ASSOCIATED WITH THIS MEDICAL DEVICE REPORT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IDENTIFIES THE RECALL STATUS AND FIELD ACTION NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED BUT DATA WAS ANALYZED. THE COMPLAINT WAS INVESTIGATED THE DAY IT WAS REPORTED. QUERIES WERE RUN TO EXTRACT VITALS FROM THE VITAL DB. THE ALERTS WERE FIRING AS INTENDED. THE AVAILABLE SYSTEM LOGS IDENTIFIED THAT THE SOFTWARE BEHAVED ACCORDING TO DESIGN PER THE PREDEFINED HEART RATE (HR) RULES. THE ALERT THAT FIRED WAS THE HR LIMIT MODERATE HIGH ALERT. THIS ALERT TRIGGERS WHEN A 10 MINUTE HR (AGGREGATE VALUE) >THE PATIENT'S UPPER LIMIT (NORMAL RANGE IS 130). 10 MINUTE PERIODIC VALUES FROM DATABASE: (B)(6) 2015 2:56 AM 87 (B)(6) 2015 3:06 AM 76 (B)(6) 2015 3:16 AM 131 THE FOLLOW ING ARE THE RULES FOR THE HR ALERTS: 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) THERE WAS NO OTHER DATA IN THE LOGS THAT WOULD HAVE PROMPTED THE ALERT TO FIRE. THIS REPORT IS BEING FILED AS THE ECARE MANAGER DEVICE WAS USED DURING AN EVENT THAT WAS FOLLOWED BY A PATIENT'S DEATH. THE DEVICE FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    THIS FOLLOW UP #2 IS SUBMITTED DUE TO AN ERROR MADE ON FOLLOW UP #1. A FIELD ACTION NUMBER WAS PROVIDED; HOWEVER, THERE IS NO FIELD ACTION ASSOCIATED WITH THIS MEDICAL DEVICE REPORT.(1125873-2015-00015).

    Description of Event or Problem · 1

    THIS SUPPLEMENTAL REPORT DOCUMENTS THE FIELD ACTION NUMBER AS THE DECISION WAS MADE POST SUBMISSION OF THE INITIAL MDR.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THEY HAD A SINGLE PATIENT'S ALERTS FIRING LATE. THEY SAW NO ISSUES WITH OTHER PATIENTS. DURING THE INVESTIGATION WITH THE USER, HE STATED THAT THE PATIENT HAD EXPIRED. HE DID NOT IMPLY THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556127 ARGUS SYSTEM ECAREMANAGER SOFTWARE V.3.9 MSX PHILIPS VISICU 865325

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death