BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 17814054 · Received September 25, 2023

    Report

    Report Number
    8030229-2023-03784
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 1, 2023
    Report Date
    July 26, 2024
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    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

    COMPLAINT DETAILS: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT THE CENTRAL NURSE'S STATION (CNS) IT WAS NOT SHOWING THE HEART RATE (HR) WHEN A TRANSMITTER IS BEING USED IN HI-Q VIEW. 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). THIS ISSUE WAS INVESTIGATED BY NKC IN WHICH THE ROOT CAUSE WAS FOUND TO BE A SOFTWARE DEFICIENCY FOR THE G5/G7 MONITOR VIEWING THE ZM TRANSMITTER IN HI-Q VIEW. COUNTERMEASURES WERE ADDED TO G5/G7 SOFTWARE VERSION 02-27 TO ADDRESS THE ISSUE. ACCORDING TO NIHON KOHDEN TECHNICAL SERVICE ACCOUNT MANAGER (NK TSAM), THE ISSUE WAS RESOLVED AFTER THE G5/G7 SOFTWARE UPDATE TO VERSIONS 02-27. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS AN ATTEMPT TO OBTAIN THE INFORMATION WERE MADE, BUT NONE WERE PROVIDED. A2 - A6 B6 B7 ATTEMPT #1 09/21/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 09/22/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: TRANSMITTER MODEL #: ZM-531PA SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 12/23/2021 UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM CNS-6801A TO PU-681RA. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM CNS-6801A TO PU-681RA. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A, PER THE FDA REQUEST. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE?

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT THE CENTRAL NURSE'S STATION (CNS) IT WAS NOT SHOWING THE HEART RATE (HR) WHEN A TRANSMITTER IS BEING USED IN HI-Q VIEW. 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. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL #: ZM-531PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATE: 12/23/2021, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT THE CENTRAL NURSE'S STATION (CNS) IT WAS NOT SHOWING THE HEART RATE (HR) WHEN A TRANSMITTER IS BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT THE CENTRAL NURSE'S STATION (CNS) IT WAS NOT SHOWING THE HEART RATE (HR) WHEN A TRANSMITTER IS BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AT THE CENTRAL NURSE'S STATION (CNS) IT WAS NOT SHOWING THE HEART RATE (HR) WHEN A TRANSMITTER IS BEING USED IN HI-Q VIEW. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834026 PU-681RA CENTRAL MONITOR SYSTEM (CNS-6801A) MHX NIHON KOHDEN CORPORATION PU-681RA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRANSMITTER| TRANSMITTER| TRANSMITTER