FDA Adverse Event
Malfunction
Summary report: N
ADVANTX LC+
MDR report key: 2092886
·
Received April 11, 2011
Report
- Report Number
- 9611343-2011-00033
- Event Type
- Malfunction
- Date Received
- April 11, 2011
- Date of Event
- March 15, 2011
- Report Date
- April 11, 2011
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K931049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMAGES ON THE FRONTAL PLANE MONITOR WERE FLICKERING INTERMITTENTLY DURING FLUOROSCOPY EXPOSURES. THE HOSPITAL STATED THAT THE IMAGE SHRINKS. THIS ISSUES MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTX LC+ | ANGIOGRAPHIC X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |