BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 23660481 · Received November 26, 2025

    Report

    Report Number
    8030229-2025-05880
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 26, 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
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SPONTANEOUSLY REBOOTED AT 2:00AM EST ON 11/05/2025. THE CNS POWERED BACK UP ON ITS OWN. ANOTHER CNS WITH THE SAME ISSUE WAS PREVIOUSLY REPORTED IN TICKET # 242729. HE ALSO MENTIONED THAT THE SOFTWARE ON THIS CNS WAS RECENTLY UPGRADED FROM VERSION 02-23 TO 02-26. 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. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 11/06/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 11/12/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 11/19/2025 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 THE CENTRAL NURSE'S STATION (CNS) SPONTANEOUSLY REBOOTED AT 2:00AM EST ON 11/05/2025. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813433 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown