FDA.reportPublic FDA data

MAUDE MDR 1531097

MDR report key
1531097
Report number
9610105-2009-00034
Event key
0
Event type
3
Date of event
2009-10-22
Date received
2009-11-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ANN LEBAR
Address
3000 N. GRANDVIEW BLVD. MAIL CODE - W450 WAUKESHA WI 53188 US
Phone
262-262-2625
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AS/3 AIRWAY MODULEHALOTHANE GAS ANALYZERGE HEALTHCARE FINLAND OYCBSG-AIO-00-04N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-1301. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PATIENT AWOKE DURING AN OPERATION, AND PULLED THE ENDOTRACHEAL TUBE FROM HER MOUTH WHEN THE INSTRUMENT WAS INSERTED INTO THE MUSCLE WALL. THE PATIENT REPORTEDLY SUSTAINED NO INJURIES AND HAS NO RECOLLECTION OF THE EVENT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.