BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12340344 · Received August 18, 2021

    Report

    Report Number
    8030229-2021-01616
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 20, 2021
    Report Date
    February 24, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY REBOOTED THEY CENTRAL NURSE'S STATION (CNS) AS A PART OF THE MONTHLY RESET ON THE CNS SYSTEMS TO KEEP THEM RUNNING CORRECTLY. WHEN THEY DID THAT, IT WAS REPORTED THAT 4 TELEMETRY TRANSMITTERS WERE NOT SHOWING UP ON THE CNS. WHILE NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) WAS ON THE PHONE WITH THE CUSTOMER, THEY STATED THAT MULTIPLE UNITS STARTED TO CHANGE BED NAMES AND WAVEFORMS THAT WERE BEING DISPLAYED WERE NO LONGER SEEN ON THE BED THEY WERE ASSOCIATED WITH. THE CUSTOMER STATED THAT THERE IS NO COMMUNICATION LOSS MESSAGE PRESENT. TECH SUPPORT CALLED THE CUSTOMER TO CONTINUE TROUBLESHOOTING THE ISSUE BEFORE SENDING TICKET TO NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS). THE CUSTOMER REPORTED THAT THE HOSPITAL'S IT STAFF REBOOTED THE UNIFIED GATEWAY SERVER AND THAT RESOLVED THE ISSUE. 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. 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

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY REBOOTED THE CENTRAL NURSE'S STATION (CNS) AS A PART OF THE MONTHLY RESET. UPON REBOOT, 4 TELEMETRY TRANSMITTERS WERE NOT SHOWING UP ON THE CNS. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) PERFORMED TROUBLESHOOTING STEPS. THE CUSTOMER STATED THEY HAD REBOOTED THE CNS. NK TS RECOMMENDED REPLACING THE BATTERIES IN ONE OF THE GZ TRANSMITTERS, WHICH DID NOT RESOLVE THE ISSUE. NK TS REQUESTED CLINICAL (CITS) ASSISTANCE WHO REBOOTED THE UNIFIED GATEWAY (UG), WHICH RESOLVED THE ISSUE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. A REVIEW OF THE SERIAL NUMBER HISTORY SHOWS NO RECURRENCE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY REBOOTED THEY CENTRAL NURSE'S STATION (CNS) AS A PART OF THE MONTHLY RESET ON THE CNS SYSTEMS TO KEEP THEM RUNNING CORRECTLY. WHEN THEY DID THAT, IT WAS REPORTED THAT 4 TELEMETRY TRANSMITTERS WERE NOT SHOWING UP ON THE CNS. WHILE NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) WAS ON THE PHONE WITH THE CUSTOMER, THEY STATED THAT MULTIPLE UNITS STARTED TO CHANGE BED NAMES AND WAVEFORMS THAT WERE BEING DISPLAYED WERE NO LONGER SEEN ON THE BED THEY WERE ASSOCIATED WITH. THE CUSTOMER STATED THAT THERE IS NO COMMUNICATION LOSS MESSAGE PRESENT. TECH SUPPORT CALLED THE CUSTOMER TO CONTINUE TROUBLESHOOTING THE ISSUE BEFORE SENDING TICKET TO NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS). THE CUSTOMER REPORTED THAT THE HOSPITAL'S IT STAFF REBOOTED THE UNIFIED GATEWAY SERVER AND THAT RESOLVED THE ISSUE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY REBOOTED THE CENTRAL NURSE'S STATION (CNS) AS A PART OF THE MONTHLY RESET ON THE CNS SYSTEMS TO KEEP THEM RUNNING CORRECTLY. WHEN THEY DID THAT, IT WAS REPORTED THAT 4 TELEMETRY TRANSMITTERS WERE NOT SHOWING UP ON THE CNS. WHILE NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) WAS ON THE PHONE WITH THE CUSTOMER, THEY STATED THAT MULTIPLE UNITS STARTED TO CHANGE BED NAMES AND WAVEFORMS THAT WERE BEING DISPLAYED WERE NO LONGER SEEN ON THE BED THEY WERE ASSOCIATED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232450 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GZ TELEMETRY TRANSMITTER(S)| GZ TELEMETRY TRANSMITTER(S)