BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12340373 · Received August 18, 2021

    Report

    Report Number
    2080783-2021-01616
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 20, 2021
    Report Date
    August 18, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ATTEMPT #1 07/22/2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT PATIENT INFORMATION AND ADDITIONAL DEVICE INFORMATION WAS NOT PROVIDED. 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. ATTEMPT #1 07/22/2021 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT PATIENT INFORMATION AND ADDITIONAL DEVICE INFORMATION WAS NOT PROVIDED. TELEMETRY TRANSMITTER(S) - GZ SERIES MODEL: NI, SN: NI.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232223 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

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