BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURONAV

    MDR report key: 17097416 · Received June 9, 2023

    Report

    Report Number
    17097416
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    September 21, 2022
    Report Date
    October 25, 2022
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EQUIPMENT MALFUNCTION. DID NOT START UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228340 NEURONAV ELECTRODE, DEPTH GZL ALPHA OMEGA ENGINEERING LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Female