BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT

    MDR report key: 2182065 · Received July 26, 2011

    Report

    Report Number
    2182065
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    WESTMED, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ON OPERATING ROOM (OR) TABLE AND WAS ANESTHETIZED. PT WAS TOTALLY DEPENDENT ON ANESTHESIA GAS MACHINE AND VENTILATOR. THE ANESTHESIA CIRCUIT ABRUPTLY CAME APART AT THE CONNECTION BETWEEN THE BAG AND PLASTIC ADAPTER. PRODUCT WAS MISSING THE TAPE THAT IS SUPPOSED TO KEEP THE BAG FROM COMING OFF.ANESTHESIA CIRCUIT IS SUPPLIED FULLY ASSEMBLED. THERE ARE THREE MAJOR PIECES TO THE ASSEMBLY WHICH INCLUDE CIRCUIT TUBING (96 INCHES LONG); SOFT GREEN RUBBER BAG FOR INFLATION AND DEFLATION PURPOSES; A WHITE PLASTIC CONNECTOR TO ATTACH THE BAG TO THE CIRCUIT. THE BAG IS SUPPOSED TO BE SECURED TO PLASTIC SOLELY BY A PRE-ASSEMBLED PIECE OF TAPE THAT IS ALSO WHITE. WHEN ASSEMBLED, THE TAPE MAKES THE GREEN BAG APPEAR TO BE SECURED BY THE WHITE PLASTIC CONNECTOR ONLY. THE GREEN BAG HAS NO MECHANISM TO HOLD ITSELF ON THE CONNECTOR OTHER THAN BY THE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI WESTMED, INC. 8204 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR