BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 23069469 · Received September 16, 2025

    Report

    Report Number
    8030229-2025-05513
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 18, 2025
    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
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EXT TACHY AND SV TACHY NOT ALARMING PROPERLY ON RHW THE CENTRAL NURSE'S STATION (CNS). SETTINGS SET FOR HR UPPER LIMIT 192-204. EXT TACHY 150 AND UP. SV TACHY ABOVE 170. WHEN HR WAS SURPASSING 170, THEY WERE NOT GETTING SV TACHY BUT INSTEAD GETTING EXT TACHY SOMETIMES OR SOMETIMES NOTHING. SHE CONNECTED THE BEDSIDE MONITOR (BSM) TO A SIMULATOR AND HAD THE HR AT ABOVE 200 BPM AND THE CNS WAS NOT ALARMING SV TACHY. WE READMITTED THE PATIENT AND TECH SUPPORT (TS) HAD HER GET PRINT OUTS FROM THE CNS FOR EVENT INVESTIGATION. TIME STAMP FOR EVENT IS 7:12 AM 09/12/25 THEY INITIAL ISSUE WAS THAT EXT TACHY WAS NOT APPEARING IN THE ARRHYTHMIA RECALL, EVEN THOUGH IT WAS ALARMING AND VISIBLE IN THE EVENT LIST FOR ONE PATIENT. THEY TESTED THE ALARMS MULTIPLE TIMES, AND THEY ARE NOW FUNCTIONING PROPERLY NOW. ALSO, ENTIRE FLOOR NOT SENDING ARRYTHMIAS TO ARRHYTHMIA RECALL OR CONNEXALL (PAGER MIDDLEWARE FOR BOLT APP). THEY ARE ONLY MONITORING 2 PATIENTS ON CONNEXALL. THE OTHER PATIENT WITH SPO2 WAS GOING THROUGH TO CONNEXALL JUST THIS PATIENT WITH ECG ALARM ISSUE WERE NOT GOING TO CONNEXALL. LATER THE BME STATED ALL ALARMS ARE CURRENTLY ROUTING THROUGH AS EXPECTED. 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: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 09/15/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. BEDSIDE MONITOR MODEL: NI. SN: NI.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EXT TACHY AND SV TACHY NOT ALARMING PROPERLY ON RHW THE CENTRAL NURSE'S STATION (CNS). SETTINGS SET FOR HR UPPER LIMIT 192-204, EXT TACHY 150 AND UP, SV TACHY ABOVE 170. WHEN HR WAS SURPASSING 170, THEY WERE NOT GETTING SV TACHY BUT INSTEAD GETTING EXT TACHY SOMETIMES OR SOMETIMES NOTHING. SHE CONNECTED THE BEDSIDE MONITOR (BSM) TO A SIMULATOR AND HAD THE HR AT ABOVE 200 BPM AND THE CNS WAS NOT ALARMING SV TACHY. THEY INITIAL ISSUE WAS THAT EXT TACHY WAS NOT APPEARING IN THE ARRHYTHMIA RECALL, EVEN THOUGH IT WAS ALARMING AND VISIBLE IN THE EVENT LIST FOR ONE PATIENT. THEY TESTED THE ALARMS MULTIPLE TIMES, AND THEY ARE NOW FUNCTIONING PROPERLY NOW. ALSO, ENTIRE FLOOR NOT SENDING ARRYTHMIAS TO ARRHYTHMIA RECALL OR CONNEXALL (PAGER MIDDLEWARE FOR BOLT APP). THEY ARE ONLY MONITORING 2 PATIENTS ON CONNEXALL. THE OTHER PATIENT WITH SPO2 WAS GOING THROUGH TO CONNEXALL JUST THIS PATIENT WITH ECG ALARM ISSUE WERE NOT GOING TO CONNEXALL. LATER THE BME STATED ALL ALARMS ARE CURRENTLY ROUTING THROUGH AS EXPECTED. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: INCIDENT SUMMARY: THE CUSTOMER REPORTED THAT ARRHYTHMIA ALARMS, INCLUDING EXTERNAL TACHYCARDIA AND SV TACHYCARDIA, WERE INTERMITTENTLY NOT APPEARING IN ARRHYTHMIA RECALL AND WERE NOT ROUTING TO THE PAGER MIDDLEWARE SYSTEM FOR ONE PATIENT AND, AT TIMES, AN ENTIRE UNIT. SPO[?] ALARMS WERE REPORTED AS ROUTING CORRECTLY, WHILE ECG-RELATED ARRHYTHMIA ALARMS WERE MISSING OR INCONSISTENT. ROOT CAUSE INVESTIGATION: THE ISSUE COULD NOT BE CONCLUSIVELY REPRODUCED OR ISOLATED TO A DEVICE MALFUNCTION. SUBSEQUENT TESTING INDICATED THAT THE ARRHYTHMIA ALARMS BEGAN FUNCTIONING AS EXPECTED, AND ALARM ROUTING TO THE PAGER MIDDLEWARE WAS RESTORED WITHOUT A CLEARLY IDENTIFIED CORRECTIVE ACTION. THE ROOT CAUSE COULD NOT BE DETERMINED. BEDSIDE MONITOR MODEL: NI SN: 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 H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EXT TACHY AND SV TACHY NOT ALARMING PROPERLY ON RHW THE CENTRAL NURSE'S STATION (CNS). SETTINGS SET FOR HR UPPER LIMIT 192-204 EXT TACHY 150 AND UP SV TACHY ABOVE 170. WHEN HR WAS SURPASSING 170, THEY WERE NOT GETTING SV TACHY BUT INSTEAD GETTING EXT TACHY SOMETIMES OR SOMETIMES NOTHING. SHE CONNECTED THE BEDSIDE MONITOR (BSM) TO A SIMULATOR AND HAD THE HR AT ABOVE 200 BPM AND THE CNS WAS NOT ALARMING SV TACHY. WE READMITTED THE PATIENT AND TECH SUPPORT (TS) HAD HER GET PRINT OUTS FROM THE CNS FOR EVENT INVESTIGATION. TIME STAMP FOR EVENT IS 7:12 AM 09/12/25 THEY INITIAL ISSUE WAS THAT EXT TACHY WAS NOT APPEARING IN THE ARRHYTHMIA RECALL, EVEN THOUGH IT WAS ALARMING AND VISIBLE IN THE EVENT LIST FOR ONE PATIENT. THEY TESTED THE ALARMS MULTIPLE TIMES, AND THEY ARE NOW FUNCTIONING PROPERLY NOW. ALSO, ENTIRE FLOOR NOT SENDING ARRYTHMIAS TO ARRHYTHMIA RECALL OR CONNEXALL (PAGER MIDDLEWARE FOR BOLT APP). THEY ARE ONLY MONITORING 2 PATIENTS ON CONNEXALL. THE OTHER PATIENT WITH SPO2 WAS GOING THROUGH TO CONNEXALL JUST THIS PATIENT WITH ECG ALARM ISSUE WERE NOT GOING TO CONNEXALL. LATER THE BME STATED ALL ALARMS ARE CURRENTLY ROUTING THROUGH AS EXPECTED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EXT TACHY AND SV TACHY NOT ALARMING PROPERLY ON RHW THE CENTRAL NURSE'S STATION (CNS). SETTINGS SET FOR HR UPPER LIMIT 192-204 EXT TACHY 150 AND UP SV TACHY ABOVE 170. WHEN HR WAS SURPASSING 170, THEY WERE NOT GETTING SV TACHY BUT INSTEAD GETTING EXT TACHY SOMETIMES OR SOMETIMES NOTHING. SHE CONNECTED THE BEDSIDE MONITOR (BSM) TO A SIMULATOR AND HAD THE HR AT ABOVE 200 BPM AND THE CNS WAS NOT ALARMING SV TACHY. WE READMITTED THE PATIENT AND TECH SUPPORT (TS) HAD HER GET PRINT OUTS FROM THE CNS FOR EVENT INVESTIGATION. TIME STAMP FOR EVENT IS 7:12 AM 09/12/25. THEY INITIAL ISSUE WAS THAT EXT TACHY WAS NOT APPEARING IN THE ARRHYTHMIA RECALL, EVEN THOUGH IT WAS ALARMING AND VISIBLE IN THE EVENT LIST FOR ONE PATIENT. THEY TESTED THE ALARMS MULTIPLE TIMES, AND THEY ARE NOW FUNCTIONING PROPERLY NOW. ALSO, ENTIRE FLOOR NOT SENDING ARRYTHMIAS TO ARRHYTHMIA RECALL OR CONNEXALL (PAGER MIDDLEWARE FOR BOLT APP). THEY ARE ONLY MONITORING 2 PATIENTS ON CONNEXALL. THE OTHER PATIENT WITH SPO2 WAS GOING THROUGH TO CONNEXALL JUST THIS PATIENT WITH ECG ALARM ISSUE WERE NOT GOING TO CONNEXALL. LATER THE BME STATED ALL ALARMS ARE CURRENTLY ROUTING THROUGH AS EXPECTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561764 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BEDSIDE MONITOR