BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ANESTHESIA CIRCUIT

    MDR report key: 117179 · Received August 25, 1997

    Report

    Report Number
    MW1012010
    Event Type
    Malfunction
    Date Received
    August 25, 1997
    Date of Event
    August 20, 1997
    Report Date
    August 21, 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

    BREATHING CIRCUIT SPLIT UPON USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ANESTHESIA CIRCUIT BREATHING CIRCUIT CAI KING SYSTEMS CORP. * NOT RECORDED OF SURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR OHMEDA ANESTHESIA MACHINE