BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 8480309 · Received April 3, 2019

    Report

    Report Number
    2112667-2019-00034
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Report Date
    April 2, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOR 18 OF THE 22 REPORTED EVENTS, A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. OF THE 18 SYSTEMS CONFIRMED FOR THE REPORTED ISSUE, 3 WERE RESOLVED BY REPLACING THE INSPIRATOR AND EXPIRATORY FLOW SENSORS, 3 BY REPLACING THE SENSOR INTERFACE BOARD, 2 BY REPLACING THE BAG TO VENT SWITCH, 1 BY REPLACING THE SENSOR INTERFACE BOARD AND CIRCUIT BOARD, 1 BY REPLACING THE CONTROL PANEL, 1 BY REPLACING THE ENHANCED SENSOR INTERFACE BOARD, FLOW SENSORS, AND THE GAS EVACUATION RESERVOIR BAG, 1 BY REPLACING TWO WORN GASKETS IN THE BREATHING SYSTEM. 1 ISSUE WAS RESOLVED BY HAVING THE FLOW CONTROL VALVE CONNECTOR TO THE VENT ENGINE CONNECTOR BOARD WAS REMOVED AND REINSERTED. 1 UNIT WAS CONFIRMED FOR THE REPORTED ERROR BY REVIEWING THE LOGS BUT A RESOLUTION COULD NOT BE IDENTIFIED. FOR 2 OF THE 22 REPORTED EVENTS, A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE. FOR 2 OF THE 22 REPORTED EVENTS, A DISTRIBUTOR PERFORMED THE CHECKOUT OF THE SYSTEM.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 22 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 1006-9305-000 ANESTHESIA GAS MACHINE HAD THERAPEUTIC OUTPUT FAILURE. 6 WERE REPORTED FOR A MALFUNCTION ERROR THAT RESULTS IN LOSS OF MECHANICAL VENTILATION, 6 ALARMED FOR LOSING ABILITY TO MECHANICALLY VENTILATE, 4 MALFUNCTIONS PREVENTING SELECTION OF MECHANICAL VENTILATION, 1 MALFUNCTION CAUSING THE LOSS OF PRESSURE MODE OF VENTILATION, 1 HAD A MANIFOLD PRESSURE ERROR PREVENTING MECHANICAL VENTILATION, 1 ALARMED FOR LOSING PRESSURE MODE AND PRESSURE SUPPORT VENTILATION NOT AVAILABLE, 1 MALFUNCTION ERROR THAT PREVENTS MECHANICAL VENTILATION, 1 MALFUNCTION PREVENTING SELECTION OF DESIRED VENTILATION MODE, 1 MALFUNCTION PREVENTING VOLUME MODE AND SYNCHRONOUS INTERMITTENT MODE OF MECHANICAL VENTILATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE 22 EVENTS, 13 DID NOT INVOLVE PATIENTS, AND 9 DID INVOLVE PATIENTS. THERE WAS NO PATIENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272299 AESTIVA 7900 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1006-9305-000

    Patients

    Seq Age Sex Outcome Treatment
    1