BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 11996803 · Received June 14, 2021

    Report

    Report Number
    2080783-2021-00338
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 14, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE NURSE REPORTED THAT THEY ARE EXPERIENCING A COMMUNICATION LOSS WITH A CENTRAL NURSE'S STATION (CNS) IN EAST AND 5 WEST. THEY STATED THERE IS CONSTRUCTION GOING ON WHICH KNOCKED OUT POWER TO NK DEVICES AND OTHER (B)(6) OWNED EQUIPMENT EARLIER IN THE DAY. POWER WAS RESTORED, BUT CNS IN 5 EAST IS IN COMM LOSS. NIHON KOHDEN STAFF ON SITE AND DEEMED THAT THE SWITCHES WERE NON FUNCTIONAL AND OPENED A TICKET WITH (B)(6). NK STAFF WORKED ON GETTING THE CONFIGURATION DONE FOR THE SWITCHES AND HEADED BACK ON SITE. THEY REPLACED THE SWITCHES, AND EVERYTHING WAS BACK UP RUNNING. DEAD SWITCHES WILL BE SENT BACK TO JUNIPER FOR INVESTIGATION. THE CNS ITSELF WAS NOT RETURNED, BUT THE SWITCHES USED WITH THE NETWORK WERE RETURNED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT THEY ARE EXPERIENCING A COMMUNICATION LOSS WITH A CENTRAL NURSE'S STATION (CNS) IN EAST AND 5 WEST. THEY STATED THERE IS CONSTRUCTION GOING ON WHICH KNOCKED OUT POWER TO NK DEVICES AND OTHER (B)(6) OWNED EQUIPMENT EARLIER IN THE DAY. POWER WAS RESTORED, BUT CNS IN 5 EAST IS IN COMM LOSS. NIHON KOHDEN STAFF ON SITE AND DEEMED THAT THE SWITCHES WERE NON FUNCTIONAL AND OPENED A TICKET WITH (B)(6). NK STAFF WORKED ON GETTING THE CONFIGURATION DONE FOR THE SWITCHES AND HEADED BACK ON SITE. THEY REPLACED THE SWITCHES, AND EVERYTHING WAS BACK UP RUNNING. DEAD SWITCHES WILL BE SENT BACK TO JUNIPER FOR INVESTIGATION. THE CNS ITSELF WAS NOT RETURNED, BUT THE SWITCHES USED WITH THE NETWORK WERE RETURNED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892776 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 TELEMETRY TRANSMITTER(S)