BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 11996789 · Received June 14, 2021

    Report

    Report Number
    8030229-2021-00338
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 15, 2021
    Report Date
    February 21, 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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE NURSE REPORTED THAT THE TELEMETRY TRANSMITTERS WERE IN COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE ROOT CAUSE FOR COMMUNICATION LOSS IS RELATED TO THIRD-PARTY DEVICES. NKA WAS ABLE TO RESOLVE THE ISSUE OF COMMUNICATION LOSS BY REPLACING DEFECTIVE NETWORK SWITCHES WHICH WERE SUPPLIED TO THE CUSTOMER BY A THIRD-PARTY. THERE IS NO EVIDENCE OF AN NK DEVICE MALFUNCTION. NO FURTHER ISSUES RELATING TO COMMUNICATION LOSS WITH THIS CNS HAVE BEEN REPORTED.

    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. 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.

    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 KAISER OWNED EQUIPMENT EARLIER IN THE DAY.

    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
    892742 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

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