MAUDE MDR 2493932

MDR report key
2493932
Report number
1419185-2011-00001
Event key
0
Event type
3
Date of event
2011-04-29
Date received
2011-07-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
1111 LAKESIDE DR. GURNEE IL 60031 US
Phone
847-847-8478
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OXYGEN FLOWMETEROXYGEN FLOWMETEROHIO MEDICAL CORPORATIONCAXUNKUNKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-2701. H

Event Narratives#

D

Patient 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.?

N

Patient 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.