BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE AESTIVA/5

    MDR report key: 3972672 · Received July 26, 2014

    Report

    Report Number
    3972672
    Event Type
    Malfunction
    Date Received
    July 26, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 26, 2014
    Manufacturer
    DATEX OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ANESTHESIA MACHINE INITIALLY SEEMED AS THOUGH THERE WAS A LEAK WHICH PRODUCED INADEQUATE TIDAL VOLUME. CRNA STATED SHE TURNED THE FLOWS UP TO COMPENSATE FOR THIS LEAK AND THE END EXPIRATORY PRESSURES BEGAN CLIMBING. UPON FURTHER EXAM THE VENT PRESSURES WERE ALSO CLIMBING. THE PATIENT WAS REMOVED FROM THE VENT AND WAS HAND VENTILATED VIA AN AMBU BAG FOR THE REMAINDER OF THE CASE. THE PATIENT WAS ALSO PLACED ON A PROPOFOL INFUSION DURING THIS TIME. THE MACHINE WAS TAGGED AND THE ROOM WAS ALSO TAGGED AS BEING OUT OF SERVICE. NO PREVIOUS INDICATIONS THAT THERE WAS A PROBLEM WITH THE MACHINE. DEVICE PASSED ALL CHECKS PRIOR TO PROCEDURE START.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437375 GE AESTIVA/5 GAS-MACHINE, ANESTHESIA BSZ DATEX OHMEDA 7900 CON *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR