BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 17726383 · Received September 11, 2023

    Report

    Report Number
    8030229-2023-03756
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 11, 2023
    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

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER DEVICE(S) WERE NOT SHOWING THE HEART RATE (HR) WHEN PLACED IN HI-Q VIEW ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE INVESTIGATION 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). THE CAUSE WAS IDENTIFIED AS THE SOFTWARE OF THE G5 MONITORING UNIT WHEN USING THE HIQ-VIEW FUNCTION. NKC PLANS TO IMPLEMENT A COUNTERMEASURE FOR THE ISSUE IN THE NEXT G5 MONITOR'S SOFTWARE VERSION, 02-27, ESTIMATED TO BE RELEASED IN AUGUST 2023. TO PREVENT THE REOCCURRENCE, UPDATE THE G5 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. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: MODEL #: ZM-530PA. SERIAL #: NI. DEVICE MANUFACTURER DATA: (B)(4). 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 Manufacturer Narrative · 0

    COMPLAINT DETAILS: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER DEVICE WAS NOT SHOWING THE HEART RATE (HR) WHEN PLACED IN HI-Q VIEW ON THE CENTRAL NURSE'S STATION (CNS). 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. 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. ATTEMPT #1 08/15/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 08/17/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. REPLY WAS RECEIVED, AND THE BIOMED ONLY PROVIDED THE CONCOMITANT MEDICAL DEVICE MODEL(S) INVOLVED WERE (3) ZM-531PA BUT DID NOT PROVIDE THE SERIAL NUMBER(S) AND STATED "I DO NOT HAVE ANY OF THE PATIENT DEMOGRAPHIC INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: MODEL #: ZM-530PA SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER DEVICE (S) WERE NOT SHOWING THE HEART RATE (HR) WHEN PLACED IN HI-Q VIEW ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER DEVICE WAS NOT SHOWING THE HEART RATE (HR) WHEN PLACED IN HI-Q VIEW ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER DEVICE WAS NOT SHOWING THE HEART RATE (HR) WHEN PLACED IN HI-Q VIEW ON THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676782 PU-681RA CENTRAL MONITOR SYSTEM (CNS-6801A) MHX NIHON KOHDEN CORPORATION PU-681RA NA

    Patients

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