BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMET XL40

    MDR report key: 2172164 · Received July 15, 2011

    Report

    Report Number
    MW5021419
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    July 14, 2011
    Manufacturer
    GRASS TECHNOLOGIES
    Product Code
    GWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PLANNED SURGICAL PROCEDURE COULD NOT BE COMPLETED AFTER PLACING PT UNDER ANESTHESIA BECAUSE THE NECESSARY EEG MONITORING COULD NOT BE PERFORMED. INTERMITTENT AND UNPREDICTABLE ARTIFACT ON THE TRACINGS WERE OF SIGNIFICANT CONCERN TO THE EEG TECH SUCH THAT THEY WERE UNABLE TO BE CONFIDENT IN THEIR ABILITY TO MONITOR FOR CHANGES IN BRAIN ACTIVITY DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMET XL40 EEG MONITOR GWQ GRASS TECHNOLOGIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization