BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERIBELL EEG HEADBAND, SMALL SIZE

    MDR report key: 23582489 · Received November 18, 2025

    Report

    Report Number
    23582489
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 17, 2025
    Manufacturer
    CERIBELL, INC.
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN ATTEMPTING TO PLACE CERIBELL EEG [ELECTROENCEPHALOGRAPHY] HEADBAND ON PATIENT, PROBE #1 DISLODGED FROM THE HEADBAND ATTACHED ONLY BY A WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862989 CERIBELL EEG HEADBAND, SMALL SIZE FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH GWQ CERIBELL, INC. C151 C151I20250129

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male