BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9293523 · Received November 7, 2019

    Report

    Report Number
    8030229-2019-00629
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 15, 2019
    Report Date
    March 17, 2020
    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
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019 CUSTOMER STATED THAT COMMUNICATION LOSS WAS REPORTED BETWEEN RNS DEVICES AND ALL GZ TRANSMITTERS. CNS MONITORS WERE NOT AFFECTED. THE DEVICE LISTED ON THIS COMPLAINT IS THE NETWORK SERVER: A/PWREDGE-R640 (S/N (B)(6). INVESTIGATION SUMMARY: DUE TO LIMITED INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED COMMUNICATION LOSS ISSUE COULD NOT BE DETERMINED. ADDITIONAL MODEL INFORMATION: D11 & C2: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS AND ARE DEVICES THAT ALSO EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: CNS'S - MODEL: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RNS'S - MODEL: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. TRANSMITTERS - MODEL: NI. S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT COMMUNICATION LOSS OCCURRED ON SITE FOR ABOUT 30-45 SECONDS AND THAT IT AFFECTED A COUPLE OF THEIR CENTRAL NURSE'S STATIONS (CNS'S), ALL OF THEIR REMOTE NETWORK STATIONS (RNS'S), AND ALL OF THEIR TRANSMITTERS.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT COMMUNICATION LOSS OCCURRED ON SITE FOR ABOUT 30-45 SECONDS AND THAT IT AFFECTED A COUPLE OF THEIR CENTRAL NURSE'S STATIONS (CNS'S), ALL OF THEIR REMOTE NETWORK STATIONS (RNS'S), AND ALL OF THEIR TRANSMITTERS. CITS TEAM FOUND THAT THERE WAS A DISCONNECT ON BOTH .10 AND .30 SEGMENT AND THAT THERE WAS A TIME ADJUSTMENT OF TWO MINUTES THAT HAPPENED ON THE PRIMARY HOST SERVER THAT WAS BEING USED AS A TIME SYNC. THEY ALSO FOUND A COMMON POINT FOR THE HOST SERVERS AND ALL OF THE MENTIONED DEVICES LOCATED ON THE 4TH FLOOR, MANAGED BY A SINGLE CISCO SWITCH. NO PATIENT HARM OR INJURY WAS REPORTED. CITS TEAM ADVISED THE CUSTOMER TO VERIFY THE TIME SETTINGS ON ALL OF THEIR CNS'S IN ORDER FOR FUTURE TROUBLESHOOTING TO TAKE PLACE. 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. ADDITIONAL MODEL INFORMATION: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS AND ARE DEVICES THAT ALSO EXPERIENCED FAILURE. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION WERE MADE, BUT NOT PROVIDED: CNS'S - MODEL: NI, S/N: NI. APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RNS'S - MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. TRANSMITTERS - MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NO SERIAL NUMBER WAS PROVIDED, SO THE AGE OF THE DEVICE IS UNKNOWN. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT COMMUNICATION LOSS OCCURRED ON SITE FOR ABOUT 30-45 SECONDS AND THAT IT AFFECTED A COUPLE OF THEIR CENTRAL NURSE'S STATIONS (CNS'S), ALL OF THEIR REMOTE NETWORK STATIONS (RNS'S), AND ALL OF THEIR TRANSMITTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085938 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 ALL OF THE RNS'S| ALL OF THE RNS'S| ALL TRANSMITTERS| ALL TRANSMITTERS| VARIETY OF CNS'S| VARIETY OF CNS'S