BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POCKET EEG DEVICE

    MDR report key: 20179758 · Received September 10, 2024

    Report

    Report Number
    20179758
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    March 25, 2024
    Report Date
    March 26, 2024
    Manufacturer
    CERIBELL INC
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CERIBELL ON FOR 1.5 HOURS, NO SEIZURE BURDEN LOADING. WHEN DEVICE SWITCHED OUT DEVICE UNABLE TO UPLOAD RECORDING. SENT TO HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223481 POCKET EEG DEVICE STANDARD ELECTROENCEPHALOGRAPH GWQ CERIBELL INC C100

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female