BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-2101 CENTRAL MONITOR

    MDR report key: 24607865 · Received March 16, 2026

    Report

    Report Number
    8030229-2026-06357
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 20, 2026
    Report Date
    May 11, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921017159
    PMA / PMN Number
    K223567
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT HE HAD JUST RECEIVED THE CENTRAL NURSE'S STATION (CNS) FROM AN OBF EXCHANGE ON A PREVIOUS TICKET (B)(4) AND THE ALARM SOUNDS WERE VERY DIM AND FAINT. THEY WILL BE PROVIDED WITH ANOTHER EXCHANGE TO RESOLVE THE ISSUE. 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 Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT HE HAD JUST RECEIVED THE CENTRAL NURSE'S STATION (CNS) FROM AN OBF EXCHANGE ON PREVIOUS TICKET (248215), AND THE ALARM SOUNDS WERE VERY DIM AND FAINT. THEY WILL BE PROVIDED WITH ANOTHER EXCHANGE TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: NK TECH SUPPORT VERIFIED THAT ALL ALARM VOLUME SETTINGS IN BOTH THE CNS APPLICATION AND WINDOWS WERE MAXIMIZED AND THAT THE ALARM SETTINGS WERE CONFIGURED CORRECTLY, BUT THE ISSUE PERSISTED THROUGH AN ALARM SOUND CHECK. AN OUT-OF-BOX FAILURE EXCHANGE WAS INITIATED, AND A REPLACEMENT DEVICE WAS SHIPPED TO THE CUSTOMER. THE RETURNED DEVICE WAS EVALUATED AT THE NK REPAIR CENTER, WHERE THE ISSUE WAS SUCCESSFULLY REPRODUCED AND ATTRIBUTED TO A MALFUNCTION IN THE SPEAKERS OR AUDIO HARDWARE CIRCUITRY. THE ROOT CAUSE WAS DETERMINED TO BE COMPONENT FAILURE DUE TO A SOFTWARE ISSUE. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 02/23/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 03/02/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 03/12/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT HE HAD JUST RECEIVED THE CENTRAL NURSE'S STATION (CNS) FROM AN OBF EXCHANGE ON A PREVIOUS TICKET (B)(4) AND THE ALARM SOUNDS WERE VERY DIM AND FAINT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT HE HAD JUST RECEIVED THE CENTRAL NURSE'S STATION (CNS) FROM AN OBF EXCHANGE ON A PREVIOUS TICKET (B)(4) AND THE ALARM SOUNDS WERE VERY DIM AND FAINT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119223 CNS-2101 CENTRAL MONITOR CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION CNS-2101 NA 04931921017159

    Patients

    Seq Age Sex Outcome Treatment
    1