BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL F BREATHING CIRCUIT

    MDR report key: 26190 · Received September 6, 1995

    Report

    Report Number
    26190
    Event Type
    Injury
    Date Received
    September 6, 1995
    Date of Event
    August 23, 1995
    Report Date
    September 6, 1995
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 8/23/95 AT 11:25 AM., PT'S BLOOD PRESSURE OF 160/100 PROGRESSIVELY INCREASED & DR ORDERED AN EMERGENCY C-SECTION WHICH WAS PERFORMED AT 1:20 PM. DURING DELIVERY, ORAL INTUBATION VIA VISUALIZED CORDS WAS ATTEMPTED BUT UNABLE TO VENTILATE BY BAG. NO CO2 WAS READY, SO ET WAS PULLED OUT, THEY WORKED A MASK VENT/OXYGENATION WITH DIFFICULTY. 02 SATURATION 80-90%, ORAL INTUBATION BUT DIFFICULT TO BAG MANUALLY. CHANGED BAG WITH GOOD AIR ENTRY. VIABLE MALE INFANT DELIVERED WEIGHING 6LBS., 5.4 OZ, APGARS 7/8. O2 WAS GIVEN TO INFANT'S FACE & GASTRIC LAVAGE OBTAINED 5-10ML FROM HIS STOMACH. HE WAS TRANSFERRED TO IMCU AT 1:40 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL F BREATHING CIRCUIT NON CONDUCTIVE ANESTHESIA CIRCUIT CAI KING SYSTEMS CORP. D373H5

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention