BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANESTHESIA BREATHING CIRCUIT

    MDR report key: 5366149 · Received January 8, 2016

    Report

    Report Number
    MW5059307
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 8, 2016
    Manufacturer
    WESTMED INC.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    DURING AN ELECTIVE SEPTOPLASTY, THE PT NEEDED TO BE TURNED. THE ANESTHESIOLOGIST WAS ASSISTING BY ADJUSTING THE ACCORDIAN TUBING ON THE ANESTHESIA BREATHING CIRCUIT. THE TUBING BETWEEN HIS HANDS SPLIT OPEN AT THE SEAM. THIS CAUSED PRESSURE IN THE TUBING TO DROP AND INADEQUATE VENTILATION TO THE PT. THE ANESTHESIOLOGIST IMMEDIATELY REMOVED THE BREATHING CIRCUIT APPARATUS AND BEGAN BAGGING THE PT MANUALLY WITH AN AMBU BAG. A NEW ANESTHESIA BREATHING CIRCUIT WAS OPENED AND ATTACHED TO THE ANESTHESIA MACHINE AND PT. LATER THIS WAS REPORTED TO MFG BY (B)(4), REGIONAL MANAGER FOR WESTMED, INC. HE REPORTED TO THIS WRITER THAT THE MFR STATED THAT THERE HAD BEEN AN IDENTIFIED MFG DEFECT. NO RECALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14968 ANESTHESIA BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT CAH WESTMED INC. 092115T56

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention