BEUDAMED
    FDA Adverse Event Death Summary report: N

    SC 7000 MONITOR

    MDR report key: 11684221 · Received April 19, 2021

    Report

    Report Number
    1220063-2021-00014
    Event Type
    Death
    Date Received
    April 19, 2021
    Date of Event
    April 7, 2021
    Report Date
    July 6, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K070566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE REPORTED MISSED ALARM DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT. ADDITIONAL INFORMATION WAS ALSO PROVIDED STATING THAT CRITICAL ALARMS DID GENERATE DURING THE PROCESS OF RESUSCITATION. AFTER REVIEW OF THE PROVIDED STRIP REPORT, IT WAS FOUND THAT THE CRITERIA FOR ASY WAS MET MULTIPLE TIMES PRIOR TO THE RESUSCITATION OF THE PATIENT. IT COULD BE DETERMINED THAT RESUSCITATION TOOK PLACE AT APPROXIMATELY 19:32:39. AFTER REVIEW OF THE LOG FILES, IT COULD BE DETERMINED THAT A SETTINGS CHANGE WAS MADE AT 19:32:12. AFTER THIS SETTINGS CHANGE, IT WAS REPORTED THAT CRITICAL ALARMS STARTED TO GENERATE. ADDITIONAL INFORMATION WAS REQUESTED AS TO WHAT CHANGE WAS MADE AT 19:32:12. IT WAS DETERMINED HOWEVER THIS INFORMATION WAS NOT AVAILABLE. ALTHOUGH THIS INFORMATION WAS NOT AVAILABLE, IT COULD BE DETERMINED THE CHANGE THAT WAS MADE WAS CONSISTENT WITH EITHER CHANGING THE HR ALARM FROM OFF TO ON, OR CHANGING THE ARR MONITORING MODE FROM OFF TO FULL OR BASIC. THIS IS BECAUSE CRITICAL ALARMS STARTED GENERATING AFTER THE CHANGE WAS MADE. THE IFU STATES THE FOLLOWING WARNING "WHEN HR ALARM IS "OFF" AND ARR MONITORING IS "OFF", ASY/VF ALARMS DO NOT SOUND UNLESS RESET MANUALLY BY THE USER." THE DEVICE WAS TESTED FOR PROPER FUNCTIONALITY AND WORKED AS DESIGNED. ALL 3 TYPES OF ALARMS WERE GENERATED AND THE TRANSMISSION TO THE CENTRAL WAS TRACED AND CONFIRMED. THERE WAS NO EVIDENCE TO SUPPORT A DEVICE MALFUNCTION OCCURRED. THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: A PATIENT WAS BEING MONITORED WITH THE SC7000 PATIENT MONITOR (HF/ ECG / SPO2 / NIBP). LATER THAT EVENING, THE NURSE REGISTERED A MISSING HEART RATE ( INDICATION: ***) AS WELL AS THE MISSING CORRESPONDING ECG CURVE AT THE MONITORING CENTER. SINCE THE CONFUSED PATIENT HAD ALREADY RELEASED HIS DIAGNOSTIC CABLE SEVERAL TIMES, THE ABOVE-MENTIONED NURSE WENT TO THE PATIENT'S ROOM AND INITIATED RESUSCITATION DUE TO THE PATIENT'S CRITICAL CONDITION. DESPITE THE MEASURES INITIATED, THE PATIENT DIED A SHORT TIME LATER. THE USER COMPLAINED THAT THERE WAS NO ALARM AT THE CENTRAL, AND THAT THE MONITOR IN THE ROOM DID NOT ISSUE CRITICAL ALARMS UNTIL AFTER RESUSCITATION HAD BEGUN.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: A PATIENT WAS BEING MONITORED WITH THE SC7000 PATIENT MONITOR (HF/ ECG / SPO2 / NIBP). LATER THAT EVENING, THE NURSE REGISTERED A MISSING HEART RATE ( INDICATION: ) AS WELL AS THE MISSING CORRESPONDING ECG CURVE AT THE MONITORING CENTER. SINCE THE CONFUSED PATIENT HAD ALREADY RELEASED HIS DIAGNOSTIC CABLE SEVERAL TIMES, THE ABOVE-MENTIONED NURSE WENT TO THE PATIENT'S ROOM AND INITIATED RESUSCITATION DUE TO THE PATIENT'S CRITICAL CONDITION. DESPITE THE MEASURES INITIATED, THE PATIENT DIED A SHORT TIME LATER. THE USER COMPLAINED THAT THERE WAS NO ALARM AT THE CENTRAL, AND THAT THE MONITOR IN THE ROOM DID NOT ISSUE CRITICAL ALARMS UNTIL AFTER RESUSCITATION HAD BEGUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587762 SC 7000 MONITOR PATIENT PHYSIOLOGICAL MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC 5203000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death