BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS NEUROWORKS CEEG

    MDR report key: 20797656 · Received November 27, 2024

    Report

    Report Number
    20797656
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 17, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    OMB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ERROR MESSAGE REGARDING DSM CONTROL ISSUE/INTERNET DURING EMU MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451967 NATUS NEUROWORKS CEEG AUTOMATIC EVENT DETECTION SOFTWARE FOR FULL-MONTAGE ELECTROENCEPHALOGRAPH OMB NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female