BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATED CIRCUIT, WICK, ADULT, 60"

    MDR report key: 2564674 · Received April 26, 2012

    Report

    Report Number
    9710644-2012-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    March 15, 2012
    Report Date
    April 25, 2012
    Manufacturer
    WESTMED, INC.
    Product Code
    CAI
    PMA / PMN Number
    K932439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT PROBLEM WAS NOT RELATED TO THE DESIGN BUT TO A DESIGN CHANGE. THE LENGTH OF THE INTERIOR WICK WAS EXTENDED BY 6" TO IMPROVE THE COSMETIC APPEARANCE OF THE DEVICE. THIS INCREASE IN LENGTH CAUSED SOME "BUNCHING" WHICH INCREASED THE RESISTANCE TO FLOW. WHILE THIS DID INCREASE RESISTANCE IT DID NOT AND WOULD NOT LEAD TO A DEATH OR SERIOUS ILLNESS. BELOW ARE THE RESULTS OF OUR INTERNAL TESTING. THE EVENT IN THIS CASE WAS DUE TO THE PT BEING PRE-OXYGENATED WITH NO GAS FLOW. OUR IFU INSTRUCTIONS STATES TO CONNECT GAS FLOW PRIOR TO ATTACHMENT TO PT. UNDER NORMAL USE THIS RESISTANCE WOULD BE UNNOTICEABLE AND HAVE NO ILL EFFECTS AS THE PT WOULD BE VENTILATED. IN THIS CASE THE PT FOUND IT "DIFFICULT TO BREATH" AS HE WAS NOT ATTACHED TO GAS. BASED ON THIS SINGLE COMPLAINT WE HAVE CHANGED BACK TO THE ORIGINAL DESIGN. THE HOSP THAT FILED THE REPORT IS CURRENTLY USING THIS PRODUCT WITH NO ISSUES WHATSOEVER.

    Description of Event or Problem · 1

    THE HEAT/HUMIDIFIED CIRCUIT WAS USED TO PRE-OXYGENATE THE PT PRIOR TO SURGERY. PT COMPLAINED HE COULD NOT GET ENOUGH AIR. THE GAS ANALYZER HAD READINGS CONSISTENT WITH ROOM AIR INDICATING THE PT WAS ENTRAINING ROOM AIR FROM AROUND THE MASK. PT WAS CHANGED TO A CONVENTIONAL CIRCUIT. THE INITIAL HEATED CIRCUIT WAS TESTED AWAY FROM THE PT AND NOTED TO HAVE A VERY HIGH RESISTANCE TO AIR FLOW IN THE INSPIRATORY LIMB. A 2ND AND 3RD CIRCUIT WAS TESTED AND FOUND TO ALSO HAVE THE SAME VERY HIGH RESISTANCE IN THE INSPIRATORY LIMB. NO PT HARM RESULTED DUE TO THE DEVICE FAILURE. MFR RESPONSE FOR WESTMED ADULT HEATED WICK CIRCUITS (PER SITE REPORTER). MFR REP CAME ONSITE DAY AFTER INCIDENT AND REPLACED WITH AN OLDER VERSION OF THE SAME PRODUCT. PEDIATRIC CIRCUIT (B)(4) WAS ALSO REPLACED WITH AN OLDER VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATED CIRCUIT, WICK, ADULT, 60" HEATED CIRCUIT, WICK, ADULT, 60", 28 V CAI WESTMED, INC. A38605HP 1123124T

    Patients

    Seq Age Sex Outcome Treatment
    1