BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAYMAR INDUSTRIES, INC.

    MDR report key: 672822 · Received January 9, 2006

    Report

    Report Number
    MW4004113
    Event Type
    Malfunction
    Date Received
    January 9, 2006
    Date of Event
    December 1, 2005
    Report Date
    December 22, 2005
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ONE OF OUR NURSES WAS WORKING IN THE O.R. PREPARING FOR THE FIRST CASE OF THE DAY, SHE SAID THAT SHE SMELLED SMOKE. UPON FURTHER INVESTIGATION, SHE NOTICED THAT A GAYMAR FW600 FLUID WARMER IN THE ROOM WAS SMOKING AND STARTING TO CATCH FIRE. THE UNIT WAS UNPLUGGED FORM THE WALLAND THE ANESTHESIA SURGERY TECHS WERE CALLED TO REMOVE THE UNIT AND TAKE IT TO THEIR SHOP AREA. WHEN THE WARMER WAS PICKED UP, IT WAS NOT BURNING, ONLY SMOLDERING AND THERE WAS FLUID NOTICED ON THE FLOOR DIRECTLY BELOW THE WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR INDUSTRIES, INC. FLUID WARMER LGZ GAYMAR INDUSTRIES, INC. FW600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *