BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 13589101 · Received February 23, 2022

    Report

    Report Number
    8030229-2022-02517
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 24, 2022
    Report Date
    April 25, 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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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) WERE BEING USED IN CONJUNCTION WITH THE CNS, BUT MODEL AND SERIAL NUMBER INFORMATION WAS NOTED AS NO INFORMATION (NI) FOR SOME OF THE DEVICES, AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT INFORMATION WAS NOT PROVIDED. CENTRAL NURSE'S STATION, MODEL: CNS-6801A, SN: (B)(4). CENTRAL NURSE'S STATION, MODEL: CNS-6801A, SN: (B)(4). GZ TELEMETRY TRANSMITTER(S), MODEL: NI, SN: NI.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ALL GZ TELEMETRY TRANSMITTERS (GZS) WERE IN COMM LOSS WITH THE CENTRAL NURSE'S STATION (CNS) AFTER A PLANNED UPGRADE/RESTART THE UNIFIED GATEWAY (UG) SERVICE. ABOUT 1.5 HOURS LATER, THE UG SERVICE WAS ABLE TO BE STARTED AGAIN, WHICH RESOLVED THE ISSUE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: FURTHER COMMUNICATION WITH THE CUSTOMER FOUND A PLANNED UNIVERSAL GATEWAY (UG) UPGRADE WAS THE SOURCE OF THE COMMUNICATION LOSS. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. COMMUNICATION LOSS IS AN ERROR MESSAGE NOTIFYING USER OF LOSS OF NETWORK COMMUNICATION BETWEEN THE MONITORING CNS OR RNS AND THAT OF THE MONITORED DEVICES. THE MESSAGE APPEARS ON AN INDIVIDUAL "TILE" ON THE CNS, CORRESPONDING TO THE COMMUNICATION LOSS OF THAT DEVICE. OTHER RELATED EVENTS THAT MAY CAUSE THE ISSUE ARE ACCIDENTALLY TURNING OFF THE DEVICE, OR ACCIDENTALLY UNPLUGGING THE NETWORK CABLE OF THE MONITORED DEVICE OR USER ERROR. COMMUNICATION LOSS MAY OCCUR DUE TO ISSUES WITH THE CUSTOMER'S NETWORK ENVIRONMENT. NETWORK ACCESS POINT OVERLOAD MAY CAUSE AN UNSTABLE NETWORK CONNECTION AND MAY CAUSE DEVICES TO RANDOMLY DROP CONNECTION. FOR TRANSMITTERS, IF THERE ARE TRANSMITTERS ASSIGNED TO ADJACENT CHANNELS OF THE NETWORK, THERE WOULD BE RADIO WAVE INTERFERENCE, AND MAY CAUSE SIGNAL LOSS. OTHER DEVICES ON THE HOSPITAL NETWORK MAY ALSO CAUSE INTERFERENCE WHICH COULD ALSO CAUSE COMMUNICATION OR SIGNAL LOSS. COMMUNICATION LOSS MAY ALSO OCCUR AFTER A POWER LOSS, AS THE NETWORK SERVER MAY NOT PROPERLY BOOT UP AFTER AN UNEXPECTED SHUTDOWN. BECAUSE MOST NETWORK AND COMM LOSS ISSUES ARE DUE TO HOSPITAL NETWORK SETTINGS, CONNECTION ERRORS, OR OTHER USE ERRORS, ISSUES OF THIS TYPE ARE UNLIKELY TO BE CAUSED BY A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ALL THE GZ TELELMETRY TRANSMITTERS (GZS) ARE IN COMMUNICATION LOSS AT THIS FACILITY. THEY HAD A PLANNED UPGRADE, AND IT CAUSED THE COMMUNICATION LOSS. THERE WAS SCHEDULED WORK AT (B)(6) TO RESTART THE UNIFIIED GATEWAY (UG) SERVICE. (B)(6) USES THE NETWORK LICENSING METHOD TO VALIDATE THE LICENSES. DUE TO UNKNOWN ISSUES, INVESTIGATION PENDING, THE UG SERVICE DID NOT START AS EXPECTED. ABOUT 1.5 HOURS LATER, THE UG SERVICE WAS ABLE TO BE STARTED AGAIN; THUS RESOLVING THE ISSUE OF THE GZS IN COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ALL GZ TELEMETRY TRANSMITTERS (GZS) WERE IN COMM LOSS WITH THE CENTRAL NURSE'S STATION (CNS) AFTER A PLANNED RESTART THE UNIFIED GATEWAY (UG) SERVICE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592156 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CNS-6801A SN (B)(6)| CNS-6801A SN (B)(6)| CNS-6801A SN (B)(6)| CNS-6801A SN (B)(6) | GZ TELEMETRY TRANSMITTER(S)| GZ TELEMETRY TRANSMITTER(S)