BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA FLEX ANESTHESIA CIRCUIT

    MDR report key: 115006 · Received August 20, 1997

    Report

    Report Number
    MW1011929
    Event Type
    Injury
    Date Received
    August 20, 1997
    Date of Event
    August 18, 1997
    Report Date
    August 19, 1997
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRACK WAS DISCOVERED AFTER LOW PRESSURE ALARM ON VENTILATOR ALARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA FLEX ANESTHESIA CIRCUIT BREATHING CIRCUIT CAI KING SYSTEMS CORP. * 1519F7

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention OHMEDA ANESTHESIA MACHINE