FDA Adverse Event
Malfunction
Summary report: N
INNOVA 2121C-IQ
MDR report key: 2590473
·
Received May 24, 2012
Report
- Report Number
- 9611343-2012-00021
- Event Type
- Malfunction
- Date Received
- May 24, 2012
- Date of Event
- March 26, 2012
- Report Date
- March 26, 2012
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- PMA / PMN Number
- K060259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM FRONTAL PLANE MONITOR WERE FLICKERING. THE USER STATED THAT WHEN THE MONITOR WAS FLICKERING THE IMAGES WERE UNUSABLE. THIS ISSUE MAY RESULT INA DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PT INJURY OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVA 2121C-IQ | FLUOROSCOPIC X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS SCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |