BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 13015099 · Received December 15, 2021

    Report

    Report Number
    2080783-2021-02116
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 15, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATIONS (CNSS) AND THE SECONDARY MONITORING SYSTEMS, THE REMOTE NETWORK STATIONS (RNSS), WERE SHOWING COMMUNICATION LOSS FOR THE ALL THE GZ TELEMETRY TRANSMITTERS. BY THE TIME THE BIOMED CALLED IN THE TICKET, MOST OF THE GZS WERE BACK UP, EXCEPT FOR THE 4 UNITS THAT REMAINED IN COMMUNICATION LOSS. THEY LATER STATED THAT AFTER REBOOTING THESE GZS, THEY CAME BACK OUT OF COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911620 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

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