BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 3000

    MDR report key: 940113 · Received October 9, 2007

    Report

    Report Number
    940113
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Date of Event
    September 15, 2007
    Report Date
    October 5, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA MACHINE CHECKED PRIOR TO INDUCTION WITHOUT PROBLEMS. LARYNGEAL MASK AIRWAY (LMA) PLACED ON THE PATIENT AND CONNECTED TO THE CIRCUIT. UNABLE TO VENTILATE PATIENT. THE LMA WAS REMOVED AND MASK CONNECTED TO THE CIRCUIT USED TO ATTEMPT TO VENTILATE PATIENT. STILL UNABLE TO VENTILATE. ORAL ENDOTRACHEAL TUBE (OET) WAS PLACED AND STILL UNABLE TO VENTILATE PATIENT. MEDICATIONS GIVEN FOR LARYNGOSPASM (THESE WERE GIVEN JUST IN CASE; THERE WAS NO CLINICAL INDICATION) AND STILL UNABLE TO VENTILATE. OET REMOVED AND REPLACED. STILL UNABLE TO VENTILATE. PATIENT'S O2 SATURATIONS DROPPED TO 45-72%. OET CONNECTED TO MANUAL RESUSCITATOR AND ABLE TO VENTILATE WITHOUT DIFFICULTY; O2 SATS THEN RETURNED TO NORMAL. SURGERY CANCELLED AND PATIENT TAKEN TO PACU. PATIENT AWAKENED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA 3000 ANESTHESIA MACHINE, VENTILATOR BSZ GE MEDICAL SYSTEMS, LLC AESTIVA 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR OTHER| OTHER