BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 10242802 · Received July 7, 2020

    Report

    Report Number
    8030229-2020-00369
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 8, 2020
    Report Date
    October 28, 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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMM LOSS WITH 2 GZ TRANSMITTERS. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMM LOSS WITH 2 GZ TRANSMITTERS. AN NK EMPLOYEE WAS ON-SITE AND ASSISTED IN RESOLVING THE ISSUE, HOWEVER, NO DETAILS WERE PROVIDED ON HOW. THEY BELIEVED THAT THE UNITS WERE NOT IN PATIENT USE BUT HE WAS NOT EXACTLY SURE. 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 DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE CNS: 2 GZ TRANSMITTERS: MODEL: GZ-130P, S/N: NI.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS IN COMM LOSS WITH 2 GZ TRANSMITTERS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704571 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 (2) GZ TRANSMITTERS| (2) GZ TRANSMITTERS