BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMITUBE

    MDR report key: 2497131 · Received March 15, 2012

    Report

    Report Number
    2497131
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 15, 2012
    Manufacturer
    WESTMED INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE HEAT/HUMIDIFIED CIRCUIT WAS USED TO PRE-OXYGENATE THE PATIENT PRIOR TO SURGERY. PATIENT 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 PATIENT HARM RESULTED DUE TO THE DEVICE FAILURE.======================MANUFACTURER RESPONSE FOR WESTMED ADULT HEATED WICK CIRCUITS (PER SITE REPORTER).======================MANUFACTURE REPRESENTATIVE CAME ONSITE DAY AFTER INCIDENT AND REPLACED WITH AN OLDER VERSION OF THE SAME PRODUCT. PEDIATRIC CIRCUIT A4354 WAS ALSO REPLACED WITH AN OLDER VERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMITUBE BREATHING CIRCUIT, HUMIDIFIED CAI WESTMED INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *