BEUDAMED
    FDA Adverse Event Death Summary report: N

    CNS-6801A

    MDR report key: 15555818 · Received October 6, 2022

    Report

    Report Number
    8030229-2022-03098
    Event Type
    Death
    Date Received
    October 6, 2022
    Date of Event
    September 3, 2022
    Report Date
    January 4, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer 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. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. 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. THE DATE OF BIRTH WILL NOT BE PROVIDED. 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. THE DATE OF BIRTH WILL NOT BE PROVIDED. 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. THE DATE OF BIRTH WILL NOT BE PROVIDED. 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: N.I 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: 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: 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.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT A PATIENT EXPIRED ON (B)(6) 2022 WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS) AND THEY WERE REQUESTING A REVIEW OF THE EVENT LOG FILES. THERE WAS CONCERN THAT THE MICROPOD UNIT THEY WERE USING WAS NOT PRODUCING ACCURATE READINGS. INVESTIGATION SUMMARY: THE CNS LOGS WERE PROVIDED BY THE CUSTOMER. HOWEVER, THE LOGS DID NOT SHOW IF THE MICROPOD WAS PRODUCING INACCURATE READINGS. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) RECOMMENDED THE CUSTOMER PERFORM AN ACCURACY CHECK ON THE MICROPOD. MULTIPLE ATTEMPTS WERE MADE TO COLLECT INFORMATION REGARDING THE RESULT OF THE ACCURACY CHECK, BUT NO RESPONSE WAS RECEIVED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. MICROPODS ARE MANUFACTURED BY ORIDION MICRO STREAM (ORIDION) - PART OF MEDTRONIC. MICROPODS ARE SENT TO THE MANUFACTURER FOR EVALUATION. BASED ON THE EVALUATIONS PERFORMED BY THE MANUFACTURER (SEE (B)(4)), GAS READING (INACCURATE READINGS) ISSUES ARE CAUSED BY THE FOLLOWING FAILURES: 1, INPUT CONNECTER ISSUES, 2. LEAK, 3. FLOW RELATED ISSUES, 4. NO COMMUNICATION, 5. MAINTENANCE NOT PERFORMED ON TIME / PREVENTATIVE MAINTENANCE, AND CO2 CALIBRATION PROCEDURE ISSUES. DEVICES EVALUATED WITH INPUT CONNECTOR ISSUES, LEAK, AND FLOW RELATED ISSUES, AND CO2 CALIBRATION PROCEDURE ISSUES WERE FOUND TO BE DUE TO A DEFECTIVE CO2 SUB-ASSEMBLY. DEPENDING ON THE FAILURE, THE CO2 SUB-ASSEMBLY MAY FAIL DUE TO A BROKEN FRS, DIRTY HOUSING OF THE FRS, A DEFECTIVE MOTOR, DAMAGED TUBING, A BAD ASSEMBLY, AND A LEAKING OPTIC BLOCK. DEVICES EVALUATED WITH NO COMMUNICATION WERE FOUND TO BE DUE TO BAD ASSEMBLY OF THE CONNECTOR. WITHOUT THE ROOT CAUSE, COUNTERMEASURES TO PREVENT RECURRENCE OF THE ISSUE COULD NOT BE IDENTIFIED. NO CORRECTIVE ACTIONS WILL BE PERFORMED AT THIS TIME. MICROPOD ISSUES ARE RECEIVED BY NKA AND ARE BEING COMMUNICATED TO THE MANUFACTURER. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: G9 MONITOR: MODEL #: NI. SERIAL #: NI. BEDSIDE MONITOR (BSM): MODEL #: NI. SERIAL #: NI. MICROPOD SIDESTREAM: MODEL #: NI. SERIAL #: NI. HAMILTON G5 VENTILATOR: MODEL #: NI. SERIAL #: NI. ADDITIONAL INFORMATION:. B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE?. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL MANUFACTURER NARRATIVE.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT EXPIRED ON (B)(6) 2022 WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS) AND THEY WERE REQUESTING A REVIEW OF THE EVENT LOG FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555560 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Death BEDSIDE MONITOR (BSM)| BEDSIDE MONITOR (BSM)| G9| G9 MONITOR| HAMILTON G5 VENTILATOR| HAMILTON G5 VENTILATORG9SIDESTREAM DEVICEBSM| MICROPOD SIDESTREAM| SIDESTREAM DEVICE