BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 11996711 · Received June 14, 2021

    Report

    Report Number
    2080783-2021-00337
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 16, 2021
    Report Date
    June 14, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE GETTING COMM LOSS FOR ALL DEVICES, BSMS AND GZS, HOSPITAL-WIDE. THE GWY SERVER WAS OFF SO THE BIOMEDICAL ENGINEER HAD POWERED IT ON. AFTER POWERING ON, NO COMM LOSS AND PATIENT VITALS CAN BE SEEN AT NURSING STATIONS. HOWEVER, THE GWY SERVER FORCEFULLY SHUTDOWN AND THEN DEVICES GO INTO COMM LOSS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL REVIEWED THE SYSTEM EVENT LOG AND SAW THAT THE GWY SERVER LICENSE EXPIRED WHICH RESULTED IN THE FORCED SHUTDOWN. SERVER KEEPS SHUTTING DOWN EVERY TIME THEY BOOT IT UP. NO PATIENT(S) WERE HARMED DURING THIS EVENT. NIHON KOHDEN TECHNICIAN SERVICE EXTENDED THE TRIAL SERVER OS LICENSE WHICH RESOLVED THE ISSUE, SERVICE STAYS POWERED ON, NOMORE COMM LOSS, CAN MONITOR PATIENTS AT NURSING STATIONS. CUSTOMER WILL GET NEW LICENSES FOR GWY SERVER, TEST SERVER, AND PRODUCTION SERVER. 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. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WAS USED IN CONJUNCTION WITH THE CNS: TRANSMITTER MODEL #: GZ-130PA SERIAL #: (B)(4) DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: (B)(4) REMOTE NURSE STATION: MODEL #: RNS-6803 SERIAL #: (B)(4) UNIQUE IDENTIFIER (UDI) #: (B)(4) SERVER: A/PWREDGE-R640 SERIAL #: (B)(4) MANUFACTURER REFERENCES FILE (B)(4)

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE GETTING COMM LOSS FOR ALL DEVICES, BSMS AND GZS, HOSPITAL-WIDE. THE GWY SERVER WAS OFF SO THE BIOMEDICAL ENGINEER HAD POWERED IT ON. AFTER POWERING ON, NO COMM LOSS AND PATIENT VITALS CAN BE SEEN AT NURSING STATIONS. HOWEVER, THE GWY SERVER FORCEFULLY SHUTDOWN AND THEN DEVICES GO INTO COMM LOSS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL REVIEWED THE SYSTEM EVENT LOG AND SAW THAT THE GWY SERVER LICENSE EXPIRED WHICH RESULTED IN THE FORCED SHUTDOWN. SERVER KEEPS SHUTTING DOWN EVERY TIME THEY BOOT IT UP. NO PATIENT(S) WERE HARMED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892566 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 A/PWREDGE-R640| BSM| GZ| RNS