BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12896866 · Received November 30, 2021

    Report

    Report Number
    2080783-2021-02018
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 30, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MODEL INFORMATION: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NI, DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) DISCHARGED A PATIENT WITHOUT ANY STAFF INPUT. WHEN THEY ATTEMPTED TO RE-ADMIT THE PATIENT, THEY NOTICED THE PATIENT INFORMATION HAD BEEN DELETED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791037 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRANSMITTER