BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 13589164 · Received February 23, 2022

    Report

    Report Number
    8030229-2022-02627
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 27, 2022
    Report Date
    May 3, 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

    THE BIOMEDICAL ENGINEER (BME) REPORTED IN (B)(4) 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 PENN PAH TO RESTART THE UNIFIIED GATEWAY (UG) SERVICE. PENN PAH 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. THEN ON (B)(6) 2022, THEY REPORTED THE SAME ISSUE HAPPENED ON (B)(6) 2022. THIS IS THE 2ND OCCURRENCE, AND THIS REPORT IS BEING REPORTED ON THIS OCCURRENCE. 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. 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 AFTER A PLANNED UPGRADE, ALL GZ TELEMETRY TRANSMITTERS (GZS) WERE IN COMM LOSS FACILITY WIDE. THE UNIVERSAL GATEWAY (UG) SERVICE DID NOT START AS EXPECTED. HOWEVER, IT WAS ABLE TO BE RESTARTED ABOUT 1.5 HOURS LATER, RESOLVING THE COMM LOSS ISSUE. THIS WAS THE SECOND OCCURRENCE OF THIS EVENT. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) NOTED THAT THE ISSUE IS RELATED TO TICKET 130687. IN TICKET 130687, TROUBLESHOOTING WAS ABLE TO DETERMINE THE ROOT CAUSE TO BE A PLANNED UG UPGRADE. THIS TICKET WAS CREATED BY NIHON KOHDEN COMPLAINT HANDLERS TO ADDRESS THE COMMUNICATION LOSS OF THE GZ DEVICES OCCURRING ON 01/24/2022 AT APPROXIMATELY 6:00AM. TICKET 130687 IS FOR COMMUNICATION LOSS ON 01/27/2022 AT APPROXIMATELY 7:00AM. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. COMMUNICATION LOSS WAS A RESULT OF THE PLANNED UG UPGRADE. A REVIEW OF THE SERIAL NUMBER HISTORY SHOWS TICKET 130687 IS RELATED TO THIS TICKET AS THE COMMUNICATION LOSS OF THE SAME DEVICE FOR THE SAME ROOT CAUSE. BOTH TROUBLESHOOTING ACTIONS DETERMINE A PLANNED UPGRADE AS THE ROOT CAUSE. A REVIEW OF THE FACILITY'S HISTORY SHOWS A SIMILAR REPORTED ISSUE (GZ DROPPED OFF CNS) ON 01/24/2022 (130790). TICKET 130790 WAS OPENED THE SAME DAY AS 130687 BUT NO REQUESTED INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED IN (B)(4) 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 PENN PAH TO RESTART THE UNIFIIED GATEWAY (UG) SERVICE. PENN PAH 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. THEN ON (B)(6) 2022, THEY REPORTED THE SAME ISSUE HAPPENED ON (B)(6) 2022. THIS IS THE 2ND OCCURRENCE, AND THIS REPORT IS BEING REPORTED ON THIS OCCURRENCE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AFTER A PLANNED UPGRADE, ALL GZ TELEMETRY TRANSMITTERS (GZS) WERE IN COMM LOSS FACILITY WIDE. THE UG SERVICE DID NOT START AS EXPECTED. HOWEVER, IT WAS ABLE TO BE RESTARTED ABOUT 1.5 HOURS LATER, RESOLVING THE COMM LOSS ISSUE. THIS WAS THE SECOND OCCURRENCE OF THIS EVENT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673016 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)