MAUDE MDR 2805402

MDR report key
2805402
Report number
3003900188-2010-00038
Event key
0
Event type
3
Date of event
2008-08-01
Date received
2010-09-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
575 MOUNTAIN AVE MURRAY HILL NJ 07974 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGENNONELINDE GAS NORTH AMERICA LLCECX07102042551116Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-09-170

Event Narratives#

D

Patient 1

THIS REPORT CONCERNS THE THIRD OUT OF THREE INDIVIDUALS INJURED IN THE PRESENT INCIDENT. OTHER CASES FOR THE SAME INCIDENT ARE: (B)(4). ON (B)(6) 2008, AN AMBULANCE IN (B)(6) WAS SENT TO AN EMERGENCY SITUATION, AS A PERSON HAD JUMPED OUT OF A WINDOW. THE PERSON WAS STILL ALIVE WHEN THE AMBULANCE ARRIVED AT THE SCENE AND ONE OF THE PARAMEDICS WANTED TO GIVE MEDICINAL OXYGEN TREATMENT (NORMAL PROCEDURE) TO THE PT. WHEN THE PARAMEDIC OPENED THE MAIN VALVE OF THE CONOXIA 2 LITER LIV CYLINDER, A LOUD BANG WAS HEARD AND AN OXYGEN FLAME CAME OUT OF THE CONOXIA CYLINDER. THE OXYGEN FLAME WENT THROUGH THE THREE LAYERS OF CLOTHS THAT THE PARAMEDIC WAS WEARING AND RESULTED IN BURN WOUNDS TO HIS BREAST (SIZE OF A HANDBALL) AND ARM. TWO POLICEMEN THAT WERE AT THE SCENE WERE ALSO SLIGHTLY INJURED (INJURIES UNK). THE PARAMEDIC THREW AWAY THE CYLINDER AFTER THE INCIDENT AND WAS TAKEN, TOGETHER WITH THE PT, TO THE NEAREST HOSPITAL (AROUND 5 MINUTES FROM THE SCENE). THE PARAMEDIC WAS TREATED IN THE HOSP FOR HIS BURN WOUNDS (MAINLY 1ST, BUT ALSO 2ND DEGREE) AND COULD RETURN TO HIS HOME LATER THAT NIGHT. ALL THE INJURED PERSONS COULD LEAVE THE HOSP AFTER NURSING AT THE FIRST AID DEPARTMENT.

N

Patient 1

THE PRESENT CASE IS ONE OUT OF 9 INCIDENT REPORTS IN CONNECTION WITH 7 LIV IGNITIONS. EVAL SUMMARY: ROOT CAUSE ANALYSIS SUMMARY - THE CAUSE OF IGNITION WITH HIGHEST PROBABILITY IS IGNITION OF HYDROCARBONS, LUBRICANT, AND/OR DEBRIS BY ADIABATIC COMPRESSION. POTENTIAL SOURCES OF HYDROCARBONS AND LUBRICANTS; LUBRICANT (FOMBLIN) MIGRATION (LUBRICANT FROM GCE MFG OF VALVE), LEACHING OF CONTAMINANTS (PHTHALATES) FROM O-RINGS IN VALVES (LUBRICANT IN SOLVENT) AND HYDROCARBON OIL, LEACHING OF CONTAMINANTS (PHTHALATES) FROM FILL CONNECTOR AT FILLING PLANT AT (B)(4). POTENTIAL SOURCES OF DEBRIS - DEBRIS FROM MFG PROCESS OF VALVE AT GCE, DEBRIS FROM FILLING PLANT AT (B)(4), DEBRIS FROM WEAR, VALVES IN USE. THE DESIGN (FILTER AND LOCATION OF COMPONENTS IN THE HIGH PRESSURE SIDE OF THE VALVE) OF THE GCE LIV VALVE 5 MICRON FILTER IS LIKELY TO CAUSE MORE SENSITIVITY TO ADIABATIC COMPRESSION HEATING THAN THE GCE OXYGEN DESIGN.