BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS

    MDR report key: 2483279 · Received March 2, 2012

    Report

    Report Number
    MW5024533
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 2, 2012
    Manufacturer
    VITAL SIGNS INC
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIRE CAUSED BY USE OF VITAL SIGNS INC BLOOD WARMER. MODEL - ENFLOW MODEL 121. SN (B)(4). EVENT REPORTED TO MFR ON FEB 27. ON FEB 24, STAFF OF UROLOGY PROCEDURE ROOM IN (B)(6) MEDICAL CTR REPORTED AN ELECTRICAL FIRE IN PROCEDURE ROOM. THE BLOOD WARMER WAS ATTACHED TO THE BOTTOM OF AN MOBILE IV POLE VIA THE CLAMP LOCATED ON BACK OF UNIT. DURING THE PROCEDURE, THE IV SOLUTION BAG WAS HUNG AT THE TOP OF THE IV POLE - STANDARD PROCEDURE. SOME OF THE SOLUTION LEAKED OUT OF THE BAG AND ONTO THE WARMER. THE SOLUTION THEN TRAVELED FROM THE CASE INTO THE WARMER'S POWER OUTLET, CAUSING AN ELECTRICAL SPARK AND INITIATING A FIRE. THE DAMAGE CONSISTED OF MELTING THE WARMER'S POWER CORD, POWER OUTLET AND THE WARMER'S EXTERIOR CASE. THERE WAS NO PT OR STAFF IN THE ROOM AT THAT TIME. NO OTHER DAMAGE REPORTED TO ADJACENT EQUIPMENT. FIRE DEPT WAS ABLE TO PUT FIRE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS WARMING UNIT, BLOOD/SOLUTION LGZ VITAL SIGNS INC ENFLOW MODEL 21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other