BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN FLOWMETER

    MDR report key: 2493932 · Received July 27, 2011

    Report

    Report Number
    1419185-2011-00001
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    April 29, 2011
    Report Date
    July 25, 2011
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    CAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUXILIARY FLOWMETER ON THE ANESTHESIA DELIVERY UNIT WAS REQUESTED FOR EVAL BUT WAS NOT PROVIDED. THE FLOWMETER PART NUMBER AND SERIAL NUMBER WAS ALSO REQUESTED BUT WAS NOT PROVIDED. CONCLUSION: WE CONCLUDE THAT THE OHIO MEDICAL OXYGEN FLOWMETER WAS FUNCTIONING PROPERLY AND DID NOT CAUSE THE FLASH FIRE ASSOCIATED WITH THIS ADVERSE EVENT. WE CONCLUDE THAT ALL OF THE CRITICAL ELEMENTS NEEDED FOR AN OPERATING ROOM FIRE WERE PRESENT AS NOTED IN THIS MEDWATCH REPORT AND WERE THE PRIMARY CONTRIBUTOR TO THIS ADVERSE EVENT. LASTLY, OUR RESPONSE IS TO EDUCATE AND IMPLEMENT BEST PRACTICES AS OUTLINED BY ECRI¿S GUIDE TO SURGICAL FIRE PREVENTION PUBLISHED IN OCTOBER 2009 TO THIS FACILITY AND THE KEY STAKEHOLDERS, MAINLY OPERATING ROOM PERSONNEL. THE ECRI DOCUMENT ALSO REFERENCES OTHER MAJOR SOCIETIES THAT HAVE ALSO DEVELOPED GUIDELINES FOR THE PREVENTION OF OPERATING ROOM FIRES, SUCH AS THE AORN, APSF, AN ASA.

    Description of Event or Problem · 1

    AS REPORTED TO OHIO MEDICAL CORPORATION FROM REPORT (B)(4): ¿ON (B)(6) 2011, PT UNDERWENT BIOPSY OF THE LEFT SUPRACLAVICULAR NODE WITH OXYGEN ADMINISTERED PER SIMPLE MASK, FLOWING AT 5 L/MIN VIA THE AUXILIARY FLOWMETER ON THE ANESTHESIA DELIVERY UNIT. DURING COAGULATION CAUTERY USING THE ESU, A FLASH FIRE OCCURRED BURNING THE MASK, OXYGEN TUBING AND SURGICAL DRAPE. THE FIRE WAS IMMEDIATELY EXTINGUISHED; HOWEVER, PT SUSTAINED FIRST AND SECOND DEGREE BURNS TO THE FACE AND LEFT SHOULDER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN FLOWMETER OXYGEN FLOWMETER CAX OHIO MEDICAL CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization