BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12045819 · Received June 22, 2021

    Report

    Report Number
    8030229-2021-00363
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    February 22, 2023
    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
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER TILES ON THE CENTRAL NURSE'S STATION (CNS) WERE GREYED OUT AND THE VITAL SIGNS WERE DISAPPEARING FOR A COUPLE OF SECONDS. THIS WAS HAPPENING EVERY 5 MINUTES. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NKTS) RECOMMENDED THE CUSTOMER CONTACT THEIR FACILITY IT DEPARTMENT FOR ASSISTANCE. AFTER SOME TROUBLESHOOTING WITH THE IT DEPARTMENT, NK TS REACHED OUT TO CLINICAL (CITS, WHO RESTARTED THE TIME SERVER, HOST SERVER, AND GATEWAY SERVER AT THE BIOMEDICAL SUPERVISOR'S REQUEST. A FURTHER LOOK AT THE FACILITIES NETWORK ENVIRONMENT FOUND THAT A FIREWALL WAS PREVENTING COMMUNICATION BETWEEN THE DEVICES. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT AND FIREWALL PERMISSIONS (USE ERROR). A REVIEW OF THE SERIAL NUMBER HISTORY SHOWS NO RECURRENCE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT GZ'S ON THE CENTRAL NURSE'S STATION (CNS) ARE GREYED OUT ALONG WITH VITAL SIGNS DISAPPEARING FOR A COUPLE OF SECONDS AND IT'S HAPPENING EVERY 5 MINUTES. PER THE CUSTOMER, THIS IS A WIDE ISSUE. TECHNICAL SERVICE (TS) ADVISED THE CUSTOMER TO CONTACT THEIR IT TEAM AND HAVE THEM TAKE A LOOK AT THEIR AP'S AND THE HOSPITAL'S SERVER. THE CUSTOMER REPORTED THAT ALL AP'S HAVE BEEN VERIFIED, BUT THE ISSUE STILL THERE. A MEMBER OF THEIR IT CALLED LATER AND REPORTED THAT ALL DEVICES WERE NOW WORKING. THEY FOUND AN ISSUE WITH A FIREWALL THAT HAD NOT GONE LIVE YET. THEIR WIRELESS IS NOW UP AND STABLE. THERE WAS NO PATIENT INJURY 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT GZ'S ON THE CENTRAL NURSE'S STATION (CNS) ARE GREYED OUT ALONG WITH VITAL SIGNS DISAPPEARING FOR A COUPLE OF SECONDS AND IT'S HAPPENING EVERY 5 MINUTES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT GZ'S ON THE CENTRAL NURSE'S STATION (CNS) ARE GREYED OUT ALONG WITH VITAL SIGNS DISAPPEARING FOR A COUPLE OF SECONDS AND IT'S HAPPENING EVERY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941146 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GZ TRANSMITTERS| GZ TRANSMITTERS