BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 17339494 · Received July 17, 2023

    Report

    Report Number
    8030229-2023-03644
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 20, 2023
    Report Date
    August 10, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT CENTRAL NURSES STATION (CNS) WAS NOT SHOWING THE ECG HEART RATE (HR) VALUES WHEN THE TRANSMITTER WAS BEING USED IN HI-Q VIEW. HOWEVER, THE TRANSMITTER WAS SHOWING THE VALUES. BME RESOLVED THE ISSUE BY MONITORING THE TRANSMITTER BY ITSELF AND CHANGING THE LEADS. NO PATIENT HARM WAS REPORTED. 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 AN ATTEMPT TO OBTAIN THE INFORMATION WAS MADE, BUT NONE WAS PROVIDED. A2 - A6 B6 B7 ATTEMPT #1 06/22/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICES. THE BME RESPONDED WITH THE CONCOMITANT MEDICAL DEVICES USED BUT NO PATIENT INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICES: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL #: ZM-531PA. SERIAL #: (B)(6) . DEVICE MANUFACTURER DATA: 23/12/2021. UNIQUE IDENTIFIER (UDI) #: (B)(6) . RETURNED TO NIHON KOHDEN: NA . ORG: MODEL #: ORG-9110A. SERIAL #:(B)(6). DEVICE MANUFACTURER DATA: 26/08/2021. UNIQUE IDENTIFIER (UDI) #: (B)(6). RETURNED TO NIHON KOHDEN: NA.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT CENTRAL NURSES STATION (CNS) WAS NOT SHOWING THE ELECTROCARDIOGRAM (ECG) AND HEART RATE (HR) VALUES WHEN THE TRANSMITTER WAS BEING USED IN HI-Q VIEW. HOWEVER, THE TRANSMITTER WAS SHOWING THE VALUES. THE BME RESOLVED THE ISSUE BY MONITORING THE TRANSMITTER BY ITSELF AND CHANGING THE LEADS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: AS A RESULT OF THE INVESTIGATION, IT WAS CONFIRMED THAT THE PHENOMENON COULD BE REPRODUCED WHEN ON THE HIQ-VIEW FUNCTION OF THE BEDSIDE MONITOR G5/G7. WHEN SWITCHING THE 6-ELECTRODE LEADS AND THE 3-ELECTRODE LEADS FOR THE ECG OF THE ZM TRANSMITTER, THE G5/G7 OPERATED TO SET THE LEAD I TO THE CHEST LEADS (C1, C2). THE CORRECT BEHAVIOR IS TO SET ONE OF THE V1 TO V6 LEADS FOR THE CHEST LEADS (C1, C2). ALTHOUGH THE CUSTOMER REPORTED THAT THE HIQ-VIEW FUNCTION WAS NOT USED WHEN THE PHENOMENON OF THE 1ST ISSUE HAPPENED, IT COULD NOT BE IDENTIFIED FROM THE LOG INFORMATION BECAUSE THE LOG INFORMATION DIDN'T INCLUDE THE HISTORY OF WHEN THE PHENOMENON HAPPENED. THE CAUSE WAS IDENTIFIED AS THE SOFTWARE OF THE G5/G7 MONITORING UNIT WHEN USING THE HIQ-VIEW FUNCTION. NKC PLANS TO IMPLEMENT A COUNTERMEASURE FOR THE ISSUE IN THE NEXT G5/G7 MONITOR'S SOFTWARE VERSION, (B)(6), ESTIMATED TO BE RELEASED IN (B)(6) 2023. TO PREVENT THE REOCCURRENCE, UPDATE THE G5/G7 MONITORS SOFTWARE ONCE THE COUNTERMEASURE SOFTWARE IS RELEASED. THE ISSUE WILL CONTINUE TO BE MONITORED AND WILL BE REASSESSED AFTER THE RELEASE OF THE NEXT SOFTWARE VERSION. ATTEMPT #1 06/22/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICES. THE BME RESPONDED WITH SOME OF THE CONCOMITANT MEDICAL DEVICES USED BUT NO PATIENT INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICES: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: (B)(6) 2021 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NA. ORG: MODEL #: ORG-9110A SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: (B)(6) 2021 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NA. G5 OR G7 MONITORING UNIT: (UNKNOWN WHICH DEVICE WAS USED) MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT CENTRAL NURSES STATION (CNS) WAS NOT SHOWING THE ECG HEART RATE (HR) VALUES WHEN THE TRANSMITTERS WERE BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT CENTRAL NURSES STATION (CNS) WAS NOT SHOWING THE ELECTROCARDIOGRAM (ECG) AND HEART RATE (HR) VALUES WHEN THE TRANSMITTERS WERE BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105255 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown G5 MONITORING UNIT.| G7 MONITORING UNIT.| ORG.| ORG.| TRANSMITTER.| TRANSMITTER.