FDA.reportPublic FDA data

MAUDE MDR 2329990

MDR report key
2329990
Report number
3003900188-2011-00029
Event key
0
Event type
3
Date received
2011-11-07
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#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GCECOMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGENNONEECX0710137* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-070

Event Narratives#

D

Patient 1

AN IGNITION INVOLVING A COMBILITE MIDIFLOW 25 E ROUGE OXYGEN VALVE (GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN) OCCURRED ON (B)(6) 2011 IN (B)(6). NO INJURY TO PATIENT OR OTHER PERSONS WAS REPORTED. A MALE PATIENT TREATED AT HOME FOR CLUSTER HEADACHE TOOK A CYLINDER (15 L), OPENED THE VALVE AND SELECTED A 7 L/MIN FLOW. TWENTY SECONDS LATER, THE PATIENT HEARD A NOISE INSIDE THE VALVE FOLLOWED BY SPARKS. THE PATIENT CLOSED THE VALVE AND BROUGHT THE CYLINDER OUTSIDE IN HIS GARDEN. THERE THE CYLINDER CONTINUED TO GENERATE SPARKS. NO PATIENT INJURY. BLACK DEPOSIT ON THE MANODETENDER AND ON THE PATIENT'S TUBE. ON (B)(4) 2011, THE VALVE WAS SHIPPED TO (B)(4) FOR INVESTIGATION AND ANALYSIS. GCE (GAS CONTROL EQUIPMENT) IS THE MANUFACTURER FOR THE PRESENT DEVICE IN EUROPE. THE (B)(4) HAS BEEN INFORMED. (B)(4) HAS A 510(K) FOR A SIMILAR PRODUCT. FDA US WILL BE INFORMED.

N

Patient 1

EVALUATION: SPONTANEOUS IGNITION IN GCE VALVE. THE VALVE IS UNDER INTENSE INVESTIGATION.