BEUDAMED
    FDA Adverse Event Death Summary report: N

    PU-681RA

    MDR report key: 23381883 · Received October 24, 2025

    Report

    Report Number
    8030229-2025-05706
    Event Type
    Death
    Date Received
    October 24, 2025
    Date of Event
    October 2, 2025
    Report Date
    January 28, 2026
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CLINICAL NURSE SPECIALIST REPORTED THAT A PATIENT PASSED AWAY WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THEIR TELE TECH REPORTED THAT THE ASYSTOLE ALARM WAS MANUALLY SILENCED, AND THE CLINICAL NURSE SPECIALIST WANTED THIS CORROBORATED BY HAVING THE DEVICE LOGS REVIEWED. THE TELE DEVICE WAS BEING MONITORED AT AN RNS, BUT THE TELE TECH WAS AT THE CNS AND SUSPECTED THE ALARM WAS MANUALLY SILENCED AT THE RNS. INVESTIGATION SUMMARY: THE DEVICE LOG FILES WERE SENT TO NK FOR ANALYSIS. NK'S TECH SUPPORT AND QA REVIEWED THE AVAILABLE CNS AND RNS LOG FILES FOR THE REPORTED BED ID, DATE, AND TIME. THE REPORTED DATE AND TIME DID NOT EXIST WITHIN THE AVAILABLE LOG DATA AND NO LOG ENTRIES CORRESPONDING TO THE SPECIFIED BED ID OR EVENT TIME WERE FOUND IN THE PROVIDED LOGS. ADDITIONAL INFORMATION AND LOGS WERE REQUESTED AND THEN SENT IN BY THE CUSTOMER. HOWEVER, NO EVIDENCE OF A SILENCED ALARM COULD BE IDENTIFIED BASED UPON REVIEW OF THE ADDITIONAL DATA. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING FIELD CONTAINS ONLY PARTIAL INFORMATION, AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 10/03/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 10/07/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 10/24/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: THE CUSTOMER PROVIDED THE ZM TRANSMITTER INFORMATION BUT COULD ONLY PROVIDE THE HOST NAME OF THE AFFECTED RNS DEVICE. NO MODEL OR SERIAL NUMBER WAS PROVIDED FOR THE RNS. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: ZM TRANSMITTER: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 10/11/2018 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NA REMOTE NETWORK STATION (RNS): MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA ADDITIONAL INFORMATION: A1 PATIENT IDENTIFIER A2 AGE AT THE TIME OF THE EVENT A3A SEX A4 PATIENT WEIGHT A5 ETHNICITY A6 RACE B4 DATE OF THIS REPORT D10 CONCOMITANT MEDICAL DEVICE G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE

    Additional Manufacturer Narrative · 0

    THE CLINICAL NURSE SPECIALIST REPORTED THAT A PATIENT PASSED AWAY WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THEIR TELE TECH REPORTED THAT THE ASYSTOLE ALARM WAS SILENCED, AND THE CLINICAL NURSE SPECIALIST WANTS THIS CORROBORATED BY HAVING THE DEVICE LOGS REVIEWED. THE TELE DEVICE WAS BEING MONITORED AT AN RNS, BUT THE TELE TECH WAS AT THE CNS AND SUSPECTED THE ALARM WAS SILENCED AT THE RNS. 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 FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: A1 - A6 ATTEMPT # 1: (B)(6) 2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: ZM TRANSMITTER: MODEL #: ZM-531PA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 10/11/2018 UNIQUE IDENTIFIER (UDI) #:(B)(4). RETURNED TO NIHON KOHDEN: NA.

    Description of Event or Problem · 0

    THE CLINICAL NURSE SPECIALIST REPORTED THAT A PATIENT PASSED AWAY WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THEIR TELE TECH REPORTED THAT THE ASYSTOLE ALARM WAS MANUALLY SILENCED, AND THE CLINICAL NURSE SPECIALIST WANTED THIS CORROBORATED BY HAVING THE DEVICE LOGS REVIEWED.

    Description of Event or Problem · 0

    THE CLINICAL NURSE SPECIALIST REPORTED THAT A PATIENT PASSED AWAY WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THEIR TELE TECH REPORTED THAT THE ASYSTOLE ALARM WAS SILENCED, AND THE CLINICAL NURSE SPECIALIST WANTS THIS CORROBORATED BY HAVING THE DEVICE LOGS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216859 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death ZM TRANSMITTER (ZM-531PA).