BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADU

    MDR report key: 874625 · Received May 23, 2007

    Report

    Report Number
    874625
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    May 22, 2007
    Report Date
    May 23, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UNIT WAS BEING USED FOR APPROXIMATELY 1.5 HOURS WHEN THE SCREEN INDICATED A "VAPORIZER FAILURE" WHICH PERSISTED WITH ALL VAPORIZERS. IT WAS NECESSARY TO OBTAIN ANOTHER ANESTHESIA UNIT IMMEDIATELY, WITH A BRIEF PERIOD OF AMBU VENTILATION DURING THE SWITCH. THERE WERE NO INJURIES OR COMPLICATIONS FOR THE PATIENT AS A RESULT OF THIS MALFUNCTION. THE UNIT WAS SENT TO THE IN-HOUSE BIOMEDICAL ENGINEERING DEPARTMENT FOR FURTHER TESTING AND EXAMINATION. THE TESTS PERFORMED SHOWED THAT THE UNIT FUNCTIONED NORMALLY FOR ALL TESTS. SINCE THE ERROR LOG SHOWED EARLIER ERRORS (IN THE SAME MONTH) OF THE SAME TYPE, NAMELY "FGC VAPORIZER FAILURE" AND "FGC LIQUID 0", THE TECHNICIAN DECIDED TO REPLACE THE "FRESH GAS CONTROL ASSEMBLY" TO ENSURE TOTAL RELIABILITY. THE QUESTIONABLE ASSEMBLY WAS SENT BACK TO THE MANUFACTURER AS PART OF A PARTS EXCHANGE. THE REPAIRED UNIT WAS TESTED AGAIN AND PASSED, SO IT WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADU ANESTHESIA MACHINE BSZ GE MEDICAL SYSTEMS, LLC AAUF02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES