MAUDE MDR 2192813

MDR report key
2192813
Report number
3003900188-2011-00028
Event key
0
Event type
3
Date received
2011-07-27
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 OXYGENNONEECX9/896335267401* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-270

Event Narratives#

D

Patient 1

AN IGNITION INVOLVING A GCE LIV OXYGEN VALVE (GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN) OCCURRED ON (B)(6) 2011 AT (B)(6) HOSPITAL CENTRE IN (B)(6). NO INJURY TO PTS OR HOSP STAFF WAS REPORTED. BASED ON PRELIMINARY INFO, IT APPEARS THAT THE IGNITION OCCURRED WHEN HOSP STAFF WAS CONNECTING A HOSE TO THE QUICK CONNECTOR OF THE VALVE. DURING THE TRANSFER OF THE PT THROUGH THE EMERGENCY ENTRANCE, THE PHYSICIAN PICKED UP A 5 L LIV OXYGEN CYLINDER FROM THE STOCK AND CAME BACK TO THE AMBULANCE. INSIDE THE AMBULANCE, THE DOCTOR REMOVED THE TAMPER PROOF EVIDENCE (THE TRANSPARENT BAG), DISCONNECTED THE RESPIRATORY HOSE FROM RESPIRATORY VEHICLE SUPPLY AND OPENED THE SHUT OFF VALVE (SOV). HE HAS TAKEN THE HOSE OF THE RESPIRATOR DEVICE AND HAS "MADE CLOSER" THE QUICK CONNECTION TO THE LOW PRESSURE OUTLET. WHEN THE STRAIGHT HOSE CONNECTION TOUCHED THE VIPR, A SPARK OCCURRED. DESPITE THE SPARK, CARRIED AWAY BY THE "ELAN", HE HAS PLUGGED BUT NOT LOCKED THE QUICK CONNECTION TO THE LOW PRESSURE OUTLET. HE HEARD A "VENT NOISE" FOLLOWED BY A BRIEF EXPLOSION WITH A YELLOW ALMOST WHITE FLAME. THE IGNITION CAUSED A SMALL BURN TO THE DOCTOR'S PANTS. THE HOSE WAS EJECTED FROM THE VALVE OUTLET, THE CYLINDER PURGED ITSELF THROUGH THE RESPIRATORY HOSE AND FELL TO THE FLOOR OF THE EMERGENCY VEHICLE. THE VALVE AND THE HOSE WILL BE SHIPPED TO (B)(4) FOR INVESTIGATION. ADD'L INFO IS EXPECTED. (B)(4) IS THE MFR FOR THE PRESENT DEVICE IN (B)(4). (B)(4) HAS A 510(K) FOR A SIMILAR PRODUCT.

N

Patient 1

ACCIDENTAL SPONTANEOUS IGNITION IN OXYGEN VALVE. THE DEVICE IS UNDER INVESTIGATION AND ANALYSIS FOR ROOT CAUSE.