FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2193109
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20286
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE REP DETERMINED THAT THE VIDEO CONTROLLER BOARD, THE IMAGE PROCESSOR BOARD, AND THE BACK PLANE NEEDED TO BE REPLACED. THE CUSTOMER DECLINED TO HAVE THE SERVICE REP REPAIR THE SYSTEM. NO FURTHER SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |