BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ANESTHESIA BREATHING CIRCUIT

    MDR report key: 4092980 · Received September 8, 2014

    Report

    Report Number
    2183502-2014-00648
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE UNUSED CORRUGATED TUBES, FROM THE SAME LOT, WERE RETURNED FOR PRODUCT EVAL. DURING VISUAL INSPECTION, NO CRACKS, HOLES, OR DEFECTS WERE DISCOVERED IN ANY OF THE RETURNED PRODUCTS. EACH TUBE WAS FUNCTIONALLY TESTED. NO LEAKS WERE OBSERVED; THE TUBES WERE FOUND TO OPERATE AS INTENDED. THE TUBES WERE THEN TENSILE TESTED. ALL STRENGTH TESTING RESULTS PASSED SPEC. THE REPORTED PRODUCT FAULT COULD NOT BE DUPLICATED. NO EVIDENCE WAS FOUND TO SUGGEST THE REPORTED EVENT WAS CAUSED BY AN INTRINSIC PRODUCT FAULT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT THE LISTED DEVICE WAS IN USE FOR 15 MINUTES WHEN THE VENTILATOR ALARMED. THE USER REPORTEDLY FOUND A TEAR IN CORRUGATED TUBING, WHICH CAUSED A LEAK IN THE SYSTEM AND THE ALARM ON THE VENTILATOR. THERE WERE NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550988 PORTEX ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL INTERNATIONAL LTD NA 2539102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK