BEUDAMED
    FDA Adverse Event Death Summary report: N

    CNS-6801A

    MDR report key: 15555947 · Received October 6, 2022

    Report

    Report Number
    2080783-2022-03098
    Event Type
    Death
    Date Received
    October 6, 2022
    Date of Event
    September 3, 2022
    Report Date
    October 6, 2022
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THEY RECENTLY HAD A PATIENT EXPIRED SO THEY REQUESTED TO HAVE THE LOG FILES LOOKED AT. ACCORDING TO THE CUSTOMER, THE PATIENT EXPIRED WHILE BEING MONITORED ON THE CENTRAL NURSE'S STATION (CNS) ON (B)(6) 2022. THE CONCERN IS THAT IF PATIENT CO2 HAD BEEN TRENDING UP AND WAS NOT REFLECTED IN THE ETCO2 MONITORING. THE CUSTOMER'S DESIRE IS TO TEST THE UNIT TO ENSURE ACCURACY TO RULE OUT MECHANICAL ISSUE. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: DATE OF BIRTH. ATTEMPT # 1: 09/09/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 09/14/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED WITH THE REQUESTED INFORMATION EXCEPT THE PATIENT'S DATE OF BIRTH. ATTEMPT # 1: 09/09/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 09/14/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED WITH THE REQUESTED INFORMATION EXCEPT THE PATIENT'S DATE OF BIRTH. ATTEMPT # 1: 09/09/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 09/14/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED WITH THE REQUESTED INFORMATION EXCEPT THE PATIENT'S DATE OF BIRTH. ADDITIONAL MODEL INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: BSM: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI. ADDITIONAL MODEL INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: HAMILTON G5 VENTILATOR: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: G9: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: SIDESTREAM: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECENTLY HAD A PATIENT EXPIRED SO THEY REQUESTED TO HAVE THE LOG FILES LOOKED AT. ACCORDING TO THE CUSTOMER, THE PATIENT EXPIRED WHILE BEING MONITORED ON THE CENTRAL NURSE'S STATION (CNS) ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004046 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Death BSM.| G9.| HAMILTON G5 VENTILATOR.| SIDESTREAM DEVICE.