FDA.reportPublic FDA data

MAUDE MDR 2066110

MDR report key
2066110
Report number
9611343-2011-00030
Event key
0
Event type
3
Date of event
2011-01-07
Date received
2011-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JOY SONSALLA
Address
3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US
Phone
262-262-2625
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANTX LC+ANGIOGRAPHIC X-RAY SYSTEMGE MEDICAL SYSTEMSIZON Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-250

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT IMAGES ON THE FRONTAL PLANE LIVE MONITOR WERE FLICKERING INTERMITTENTLY DURING FLUOROSCOPY EXPOSURES. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PATIENT INJURY OR DEATH REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

N

Patient 1

THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 9611343-2011-00001.