BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMMUNICATION GATEWAY SERVER

    MDR report key: 8725331 · Received June 21, 2019

    Report

    Report Number
    2032233-2019-00232
    Event Type
    Death
    Date Received
    June 21, 2019
    Date of Event
    March 12, 2019
    Report Date
    August 14, 2019
    Manufacturer
    NKUS LAB
    Product Code
    MHX
    UDI-DI
    00851725007092
    PMA / PMN Number
    K083271
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ON (B)(6) 2019 IT WAS REPORTED THAT NURSES WERE NOT RECEIVING TECHNICAL ALARMS ON VOLT PHONES. CUSTOMER HAS 3 TECHNICAL ALARMS: LEADS OFF, SPO2 PROBE DISCONNECTED, AND CANNOT ANALYZE. THESE THREE ALARMS DO NOT GO TO THE NURSE PHONES SO CUSTOMER TRIED TO CHANGE THE ALARM PRIORITY TO WARNING. THESE EVENTS WERE ALARMING CORRECTLY ON THE MONITORING SYSTEM BUT EVEN AFTER THE PRIORITY CHANGE, THEY STILL ARE NOT PUSHING TO THE PHONES. CUSTOMER'S VOLT PHONE USES A SYSTEM CALLED CONNEXALL TO GET ALARMS PUSHED OVER FROM THE PAGER GATEWAY. ALARMS OTHER THAN THE THREE TECHNICAL ALARMS MENTIONED ABOVE ARE CROSSING OVER WITHOUT ISSUES. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: NK NETWORK TEAM LOOKED AT THE ISSUE AND NOTED THAT SERVER SOFTWARE DOES NOT HAVE A SETTING (DOES NOT DISCRIMINATE) WHICH ALARMS TO SEND AND WHICH DO NOT. IT WAS ADVISED THAT CUSTOMER AND/OR NK CAS VERIFY THE ALARM SETTINGS AT THE CNS/BEDSIDE DEVICE LEVEL. THE SPECIFIC SETTINGS AT THE CNS/BESIDE MONITOR COULD NOT BE CONFIRMED. CUSTOMER WAS ADVISED THAT ONLY ARRHYTHMIA RECALL ENABLED ALARMS WILL GET PUSHED VIA THE PAGER SYSTEM; AS OPPOSED TO THE PRIORITY OF THE ALARMS AS CUSTOMER SUSPECTED. SERVICE HISTORY FOR THIS PAGER GATEWAY SOFTWARE SHOWS NO PREVIOUS INCIDENTS. SERVICE HISTORY FOR THIS CUSTOMER SHOWS PAGER SYSTEM HAS NOT EXPERIENCE ADDITIONAL INCIDENTS SINCE (B)(6) 2019. ALTHOUGH THE ROOT CAUSE COULD NOT BE CONFIRMED, IT IS SUSPECTED TO BE RELATED TO ARRHYTHMIA RECALL SETTINGS. ADDITIONAL INFORMATION: DATE OF DEATH, DATE OF THIS REPORT, DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT, TYPE OF REPORT, DATE REPORT SENT TO FDA, DATE REPORT SENT TO MANUFACTURER, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, IF FOLLOW-UP, WHAT TYPE? ADDITIONAL INFORMATION , EVENT PROBLEM AND EVALUATION CODES, ADDITIONAL MANUFACTURER NARRATIVE. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: DATE OF BIRTH, ETHNICITY, RACE, SERIAL #, APPROXIMATE AGE OF DEVICE: UNABLE TO DETERMINE AGE OF DEVICE AS NO SERIAL # PROVIDED DEVICE MANUFACTURE DATE: UNABLE TO DETERMINE MANUFACTURER DATE AS NO SERIAL #, PROVIDED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER STATED THAT THE COMMUNICATION GATEWAY SERVER, SECONDARY MONITORING SYSTEM, DID NOT SEND CHECK LEADS ALARMS TO THE VOLT PHONES. PATIENT FOUND DECEASED AND DID NOT SURVIVE CODE BLUE.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER STATED THAT THE COMMUNICATION GATEWAY SERVER, SECONDARY MONITORING SYSTEM, DID NOT SEND CHECK LEADS ALARMS TO THE VOLT PHONES. PATIENT FOUND DECEASED AND DID NOT SURVIVE CODE BLUE. THE SERVER GETS ITS INFORMATION FROM THE CENTRAL MONITORING SYSTEM APPLICATION. THE INFORMATION IT GETS IS FROM THE ARRHYTHMIA RECALL PAGE AND ONLY SENDS ALARMS SPECIFIC TO THIS TYPE OF ALARM SETTING. THE TECHNICAL ALARMS ARE NOT ENABLED IN THIS SITUATION, THEY WILL NOT BE PUSHED BY THE NK SERVER OUT TO THE PHONES, SUCH AS THE CHECK LEADS ALARMS. DURING SERVER IMPLEMENTATION, WHEN THE SERVER WAS CONFIGURED WITH THE HOSPITAL'S NEEDS IN MIND, THE OPTION FOR CHECK LEADS COULD HAVE BEEN ENABLED IN THE SERVER APPLICATION AT THIS STAGE. THIS A CAN STILL BE DONE. IT IS NOT THE PRIORITY OF THE ALARM THAT ALLOWS IT TO PUSH, BUT THE TYPE OF ALARM. WITH THE EXCEPTION OF "CHECK LEADS", ONLY THE ARRHYTHMIA RECALL ENABLED ALARMS WILL BE SENT TO THE PHONES VIA THE COMMUNICATION GATEWAY SERVER. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOME AVAILABLE. THE VOLT PHONE AND CNS ARE USED IN CONJUNCTION WITH THE COMMUNICATION GATEWAY SERVER.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER STATED THAT THE COMMUNICATION GATEWAY SERVER, SECONDARY MONITORING SYSTEM, DID NOT SEND CHECK LEADS ALARMS TO THE VOLT PHONES. PATIENT FOUND DECEASED AND DID NOT SURVIVE CODE BLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518389 COMMUNICATION GATEWAY SERVER COMMUNICATION GATEWAY SERVER MHX NKUS LAB CGS-9001 NOT APPLICABLE 00851725007092

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| O VOLT PHONES,CNS,| VOLT PHONES.| VOLT PHONESCNS