FDA Adverse Event
Malfunction
Summary report: N
ADVANTX LC+
MDR report key: 2613423
·
Received June 8, 2012
Report
- Report Number
- 9611343-2012-00022
- Event Type
- Malfunction
- Date Received
- June 8, 2012
- Date of Event
- June 1, 2012
- Report Date
- June 1, 2012
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- PMA / PMN Number
- K931049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 EXAM ROOM LIVE MONITOR WERE FLICKERING. THE USER STATED THAT WHEN THE MONITOR WAS FLICKERING THE IMAGES WERE UNUSABLE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTX LC+ | ANGIOGRAPHIC X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS SCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |