BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 9351220 · Received November 20, 2019

    Report

    Report Number
    8030229-2019-00671
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 23, 2019
    Report Date
    March 9, 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
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019 CUSTOMER SUBMITTED THE LOG ENTRY FROM THE FACILITY STATING THAT "10/23 1440 COMM LOSS FOR 12 SECONDS." CUSTOMER STATED THEY COULD NOT PROVIDE ANY INFORMATION REGARDING THE ENTRY NOTE. INVESTIGATION CONCLUSION: DUE TO THE LACK OF INFORMATION AVAILABLE, AN INVESTIGATION INTO THE REPORTED ISSUE IS NOT CURRENTLY POSSIBLE. NO RISK ASSESSMENT COULD BE PERFORMED. ADDITIONAL DEVICE INFORMATION: D11 & C2 CONCOMITANT MEDICAL DEVICE INFORMATION: THE CUSTOMER STATED THAT THE CNS WAS MONITORING GZ TELEMETRY TRANSMITTERS, BUT NO MODEL OR SERIAL NUMBERS WERE PROVIDED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT ON LOG 3, 6TH FLOOR (B)(6) 2019 AT 1440 COMM LOSS FOR 12 SECONDS. THE CUSTOMER STATED THAT ALL COMMUNICATION LOSS ISSUES ARE ON THE CENTRAL NURSE'S STATION (CNS) AND MONITORING GZ TELEMETRY TRANSMITTERS. THIS TICKET HAS BEEN CREATED TO DOCUMENT THE DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT ON LOG 3, 6TH FLOOR (B)(6) 2019 AT 1440 COMM LOSS FOR 12 SECONDS. THE CUSTOMER STATED THAT ALL COMMUNICATION LOSS ISSUES ARE ON THE CENTRAL NURSE'S STATION (CNS) AND MONITORING GZ TELEMETRY TRANSMITTERS. THIS FACILITY ONLY USES THE CNS-6801A MODELS. THIS TICKET HAS BEEN CREATED TO DOCUMENT THE DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. 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 INFORMATION: THE CUSTOMER STATED THAT THE CNS WAS MONITORING GZ TELEMETRY TRANSMITTERS, BUT NO MODEL OR SERIAL NUMBERS WERE PROVIDED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT ON LOG 3, 6TH FLOOR (B)(6) 2019 AT 1440 COMM LOSS FOR 12 SECONDS. THE CUSTOMER STATED THAT ALL COMMUNICATION LOSS ISSUES ARE ON THE CENTRAL NURSE'S STATION (CNS) AND MONITORING GZ TELEMETRY TRANSMITTERS. THIS TICKET HAS BEEN CREATED TO DOCUMENT THE DEPARTMENT LOGS FROM THE HOSPITAL. THE HOSPITAL WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141911 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 GZ TRANSMITTERS| GZ TRANSMITTERS