BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POCKET EEG DEVICE

    MDR report key: 16938498 · Received May 16, 2023

    Report

    Report Number
    16938498
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    March 4, 2023
    Report Date
    April 23, 2023
    Manufacturer
    CERIBELL, INC.
    Product Code
    OMB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CERIBELL EEG MONITOR APPROPRIATELY PLACED ON PATIENT WOULD NOT TRANSMIT A REPORT WITH CONFIRMED WI-FI CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184352 POCKET EEG DEVICE AUTOMATIC EVENT DETECTION SOFTWARE FOR FULL-MONTAGE ELECTROENCEPHALOGRAPH OMB CERIBELL, INC. C100 L10188

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Male