BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS GS

    MDR report key: 2182172 · Received July 25, 2011

    Report

    Report Number
    2182172
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    September 21, 2007
    Report Date
    October 10, 2007
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TAKEN TO SURGERY FOR BOWEL OBSTRUCTION. PATIENT REGURGITATED WITH INTUBATION. ANESTHESIA MACHINE DID NOT PASS LEAK TEST BEFORE CASE. THE ANESTHESIA CIRCUIT WAS CHANGED AND RE-TESTED AND ALL SYSTEMS PASSED. AFTER INDUCTION OF ANESTHESIA, AFTER APPROXIMATELY 7 MINUTES OF NORMAL MACHINE OPERATION, THE RESEVOIR BAG COMPLETELY EMPTIED AND NO BREATHS WERE GIVEN IN VOLUME CONTROL MODE. ALL CONNECTIONS WERE TIGHT AND PATIENT WAS CONNECTED TO THE CIRCUIT. THE FRESH GAS FLOW WAS INCREASED MARKEDLY WITH NO IMPROVEMENT. FLUSH VALVE COULD NOT INFLATE BAG. THE MACHINE WAS SWITCHED TO MANUAL MODE AND AGAIN WITH POP-OFF VAVLE CLOSED, COULD NOT DELIVER POSITIVE PRESSURE. AN AMBU BAG WAS USED TO VENTILATE PATIENT. ANESTHESIA TECHNICIANS ENTERED THE ROOM AND CHANGED CIRCUITS ON THE MACHINE, RECHECKED MACHINE, AND RECONNECTED TO THE PATIENT WITH NO FURTHER FAILURE THROUGHOUT THE DURATION OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS GS GAS-MACHINE, ANESTHESIA BSZ DRAEGER MEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NO OTHER THERAPIES