BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12340405 · Received August 18, 2021

    Report

    Report Number
    2080783-2021-01477
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 20, 2021
    Report Date
    August 18, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AROUND 10:15 AM ( (B)(6) TIME) THE CENTRAL NURSE'S STATION (CNS) SHUT OFF AND THEN REBOOTED. THE CUSTOMER STATED THAT AT 10:13 AM, THEY NOTICED THAT THE PATIENT DATA HAD STOPPED BEING STORED ON THE CNS, AND THEN THE UNIT SHUT OFF. THEY STATED THAT AFTER THE REBOOT THE CNS CAME BACK UP AND IS RUNNING WITHOUT ANY FURTHER ISSUES AND NO ERRORS MESSAGES. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED IF THERE IS A PROBLEM WITH THE HDDS, AND THE CUSTOMER CONFIRMED THE HDDS ARE FINE WITH NO ERRORS OR PROBLEMS. NO PATIENT HARM WAS REPORTED. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CNS, BUT MODEL AND SERIAL NUMBER INFORMATION WAS NOTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT INFORMATION WAS NOT PROVIDED. TELEMETRY TRANSMITTER(S) - GZ SERIES: MODEL: NI, SN: NI.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AROUND 10:15 AM ( (B)(6) TIME) THE CENTRAL NURSE'S STATION (CNS) SHUT OFF AND THEN REBOOTED. THE CUSTOMER STATED THAT AT 10:13 AM, THEY NOTICED THAT THE PATIENT DATA HAD STOPPED BEING STORED ON THE CNS, AND THEN THE UNIT SHUT OFF. THEY STATED THAT AFTER THE REBOOT THE CNS CAME BACK UP AND IS RUNNING WITHOUT ANY FURTHER ISSUES AND NO ERRORS MESSAGES. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED IF THERE IS A PROBLEM WITH THE HDDS, AND THE CUSTOMER CONFIRMED THE HDDS ARE FINE WITH NO ERRORS OR PROBLEMS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232283 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 TELEMETRY TRANSMITTER(S)