FDA.reportPublic FDA data

MAUDE MDR 1822960

MDR report key
1822960
Report number
1822960
Event key
0
Event type
3
Date of event
2010-08-04
Date received
2010-08-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SODASORBABSORBENT, CARBON-DIOXIDEW.R. GRACE AND COMPANYCBLLFUNKNOWNUNK Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-08-120

Event Narratives#

D

Patient 1

DEFECTIVE SODA-LIME CANNISTER ISSUE. RECEIVED CALL FROM ANESTHESIA TECH. SHE SAID THE ANESTHESIOLOGIST WAS NOT ABLE TO VENTILATE THE PATIENT IN OR AND THEY HAD TO SWITCH OUT THE ANESTHESIA MACHINE WITH ONE FROM ANOTHER OR. I CHECKED THE MACHINE AND FOUND ONE OF THE SODA-LIME PACKS TO BE THE PROBLEM, IT DID NOT HAVE ANY HOLES IN THE BOTTOM OF IF TO ALLOW FLOW THROUGH IT. AESTIVA ANESTHESIA MACHINE.HEALTH PROFESSIONAL'S IMPRESSION:VISUALLY SEE THE HOLES INTENDED TO BE ON THE BOTTOM OF THE FILTER HAD NOT BEEN CUT OUT OF THE PLASTIC. MANUFACTURING FLAW.