BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BREATHING CIRCUIT

    MDR report key: 25423 · Received September 11, 1995

    Report

    Report Number
    MW1006899
    Event Type
    Malfunction
    Date Received
    September 11, 1995
    Date of Event
    August 10, 1995
    Report Date
    September 7, 1995
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    KINK IN INNER CHANNEL OF BREATHING CIRCUIT AT PROXIMAL END. DIFFICULT TO DETECT. REMOVED FROM MACHINE BEFORE PT ENTERED ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL BREATHING CIRCUIT BREATHING CIRCUIT CAI KING SYSTEMS CORP. 0373H5

    Patients

    Seq Age Sex Outcome Treatment
    1 *