BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 11532772 · Received March 19, 2021

    Report

    Report Number
    2080783-2021-00143
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 16, 2021
    Report Date
    March 19, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) RECENTLY LOST POWER, AND AFTER IT WAS REBOOTED, SEVERAL BED TILES WERE NOTICED TO HAVE THE ALARM ICON TURNED RED AND HAS AN "X" OVER IT. THE CUSTOMER STATED THAT THE ALARMS WERE STILL ARE BEING ACTIVATED ACCORDING TO THE SETTINGS ON THE CNS, AND THERE HAS BEEN NO ISSUE WITH PATIENT MONITORING, BUT THEY JUST CANNOT HEAR THE ALARMS. NK CLINICAL SPOKE TO THE CUSTOMER, AND IT WAS DISCOVERED THAT TELEMETRY TECHS WORKING AT A REMOTE STATION HAD SILENCED THE ALARMS AND DID NOT INFORM OTHERS AT THIS CNS. THEY COULD ONLY SEE THE BANNER BECAUSE IT WAS SILENCED ELSEWHERE. THE ORANGE BELL WAS GIVING THEM THE REMAINING COUNTDOWN AFTER THE ALARMS WAS SILENCED. NK CLINICAL AND THE BIOMED THAT CALLED WERE ABLE TO RE-ENGAGE THE ALARM SOUNDS AT THE CNS AND ALL ALARMS ARE NOW SOUNDING AND FULLY WORKING. NO PATIENT HARM WAS REPORTED. ON 02/25/2021, WHEN THE BIOMED WAS CONTACTED FOR CONCOMITANT DEVICE INFORMATION, THEY STATED THEY ARE NOT AWARE OF ANY CNSS THAT WENT DOWN AND THE CONCOMITANT DEVICE INFORMATION WAS NOT PROVIDED. ATTEMPT #1: 02/19/2021: EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: 02/22/2021: EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. ON 02/25/2021, WHEN THE BIOMED WAS CONTACTED FOR CONCOMITANT INFORMATION, THEY STATED THEY ARE NOT AWARE OF ANY CNSS THAT WENT DOWN AND THE CONCOMITANT DEVICE INFORMATION AND PATIENT INFORMATION WAS NOT PROVIDED. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. ATTEMPT #1: 02/19/2021: EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: 02/22/2021: EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. ON 02/25/2021, WHEN THE BIOMED WAS CONTACTED FOR CONCOMITANT INFORMATION, THEY STATED THEY ARE NOT AWARE OF ANY CNSS THAT WENT DOWN AND THE CONCOMITANT DEVICE INFORMATION AND PATIENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) RECENTLY LOST POWER, AND AFTER IT WAS REBOOTED, SEVERAL BED TILES WERE NOTICED TO HAVE THE ALARM ICON TURNED RED AND HAS AN "X" OVER IT. THE CUSTOMER STATED THAT THE ALARMS WERE STILL ARE BEING ACTIVATED ACCORDING TO THE SETTINGS ON THE CNS, AND THERE HAS BEEN NO ISSUE WITH PATIENT MONITORING, BUT THEY JUST CANNOT HEAR THE ALARMS. NK CLINICAL SPOKE TO THE CUSTOMER, AND IT WAS DISCOVERED THAT TELEMETRY TECHS WORKING AT A REMOTE STATION HAD SILENCED THE ALARMS AND DID NOT INFORM OTHERS AT THIS CNS. THEY COULD ONLY SEE THE BANNER BECAUSE IT WAS SILENCED ELSEWHERE. THE ORANGE BELL WAS GIVING THEM THE REMAINING COUNTDOWN AFTER THE ALARMS WAS SILENCED. NK CLINICAL AND THE BIOMED THAT CALLED WERE ABLE TO RE-ENGAGE THE ALARM SOUNDS AT THE CNS AND ALL ALARMS ARE NOW SOUNDING AND FULLY WORKING. NO PATIENT HARM WAS REPORTED. ON 02/25/2021, WHEN THE BIOMED WAS CONTACTED FOR CONCOMITANT DEVICE INFORMATION, THEY STATED THEY ARE NOT AWARE OF ANY CNSS THAT WENT DOWN AND THE CONCOMITANT DEVICE INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419408 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1