BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL F2

    MDR report key: 235505 · Received August 13, 1999

    Report

    Report Number
    235505
    Event Type
    Injury
    Date Received
    August 13, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 12, 1999
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER PT WAS INDUCED FOR SURGERY, UNABLE TO MANUALLY VENTILATE THROUGH FACE MASK OR ENDOTRACHEAL TUBE. PT BECAME SEVERELY HYPOXIC AND BRADYCARDIC. ONCE CIRCUIT ON ANESTHESIA MACHINE WAS CHANGED, VENTILATION WAS SUCCESSFUL. PT DEVELOPED SEIZURES AFTER EVENT. CURRENT NEURO STATUS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT CAI KING SYSTEMS CORP. 0 346R-6133 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| S