FDA.reportPublic FDA data

MAUDE MDR 8189912

MDR report key
8189912
Report number
MW5082415
Event key
0
Event type
3
Date of event
2018-07-24
Date received
2018-12-20
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GAS CYLINDER PRESSURE REGULATORREGULATOR, PRESSURE, GAS CYLINDERAIRGAS USACANI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-2001. O

Event Narratives#

D

Patient 1

ON (B)(6) 2018, SERVICE TECH DISCOVERED ODOR AT CARBON DIOXIDE GAS MANIFOLD COMING FROM ONE CYLINDER. CO2 OUTLETS WERE TESTED. TESTS INDICATED ELEVATED LEVELS OF HYDROCARBONS IN THE CO2 LINE, NOT MEETING NFPA99 STANDARDS. CO2 REGULATOR AND PARTS OF MANIFOLD WERE FOUND DAMAGED AND WERE REPLACED. CO2 WAS USED DURING LAPAROSCOPIC SURGERY FOR INSUFFLATION OR DURING CARDIOVASCULAR SURGERY FOR OXYGEN DISPLACEMENT / SURGICAL FIRE PREVENTION.