FDA Adverse Event
Malfunction
Summary report: N
INNOVA 2000
MDR report key: 2459252
·
Received February 10, 2012
Report
- Report Number
- 9611343-2012-00005
- Event Type
- Malfunction
- Date Received
- February 10, 2012
- Date of Event
- January 9, 2012
- Report Date
- January 9, 2012
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- MQB
- PMA / PMN Number
- K022322
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 EXAM ROOM LIVE MONITOR WERE FLICKERING DURING FLUOROSCOPY EXPOSURES. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH WAS REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVA 2000 | FLUOROSCOPIC X-RAY SYSTEM | MQB | GE MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |