BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATED AND HUMIDIFIED ANESTHESIA WICK BREATHING

    MDR report key: 1171973 · Received September 22, 2008

    Report

    Report Number
    MW5008375
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    WESTMED
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AT APPROX 06:00 THE ANESTHESIOLOGIST COMPLETED THE SET-UP OF THE CIRCUIT IN PREPARATION FOR USE FOR THE FIRST PATIENT OF THE DAY. THE CIRCUIT WAS REMOVED FROM ITS PACKING, FILLED WITH THE WATER SOLUTION CONTAINED WITH THE PACKING, CONNECTED TO THE ANESTHESIA MACHINE AND THE HEATER CONTROLLER, AND THEN ESTABLISHED A FLOW OF 5 LITERS/MINUTE OF OXYGEN. THE ANESTHESIOLOGIST HAD TO LEAVE THE ROOM TO GET MORE EQUIPMENT FOR THE CASE. AT APPROX 06:07 OPERATING ROOM STAFF SMELLED SMOKE AND SAW THROUGH THE HALLWAY ROOM DOOR THAT THE COMPLETE CIRCUIT WAS ON FIRE. ONE PERSON TURNED OFF THE OXYGEN SUPPLY AND ANOTHER GOT A HALLWAY FIRE EXTINGUISHER -ABC DRY CHEMICAL TYPE- AND EXTINGUISHED THE FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATED AND HUMIDIFIED ANESTHESIA WICK BREATHING HEATED HUMIDIFICATION CIRCUIT, PEDIATRIC, 72 INCHES CAI WESTMED A4334 94622

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability MODEL 200| ANAMED -NOW WESTMED- ANESTHESIA CONTROLLER| LAST INSPECTED MARCH 2008