BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENLON SIGME DELTA SEVOFLURANE ANESTHETIC VAPORIZER

    MDR report key: 1392809 · Received May 20, 2009

    Report

    Report Number
    MW5011201
    Event Type
    Injury
    Date Received
    May 20, 2009
    Date of Event
    September 27, 2008
    Report Date
    May 20, 2009
    Manufacturer
    PENLON LTD.
    Product Code
    CAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I AM AN ANESTHESIOLOGIST WHO WAS USING A NEW ANESTHESIA MACHINE MADE BY PENLON LTD AND SOLD AND DISTRIBUTED BY PARAGON SERVICE -SALINE, MI-THE MODEL OF THE MACHINE IS PARAGON SC430. THIS MACHINE INCLUDED A NEW PENLON SIGMA DELTA SEVOFLURANE VAPORIZER. WITHIN ONE MONTH OF USING THE NEW MACHINE, I EXPERIENCED A VARIETY OF NEW SYMPTOMS INCLUDING INABILITY TO CONCENTRATE, FATIGUE, TREMOR, AND LIGHT HEADEDNESS. FOLLOWING CONTINUED DAILY USE OF THE VAPORIZER, I WAS EMERGENTLY ADMITTED TO THE HOSPITAL WITH LIFE THREATENING DEPRESSION, ANXIETY, INVOLUNTARY MUSCLE TWITCHING, AND WAS NOTED TO BE HYPOTHYROID ON ADMISSION. UPON RETURN TO WORK, I DETECTED A LARGE LEAK IN THE SIGMA DELTA VAPORIZER. SUBSEQUENT RESEARCH ON THIS MODEL REVEALED IT WAS RECALLED BY BOTH THE MANUFACTURERS IN OTHER COUNTRY IN 2006. THIS VAPORIZER WAS NOTED TO DEGRADE GENERIC SEVOFLURANE TO HYDROFLUORIC ACID CAUSING CORROSION WITHIN THE VAPORIZER AND SUBSEQUENT LEAKS. LEVELS OF HYDROGEN FLUORIDE HAVE BEEN SHOWN TO EXCEED 600 PPM IN THIS VAPORIZER, WITH THE OSHA RECOMMENDATION AT LESS THAN 3PPM. MY CLINICAL SYMPTOMS ARE VERY CONSISTENT WITH FLUORIDE TOXICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENLON SIGME DELTA SEVOFLURANE ANESTHETIC VAPORIZER NONE CAD PENLON LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R