FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2093120
·
Received May 3, 2011
Report
- Report Number
- 1720753-2011-06894
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 13, 2011
- Report Date
- May 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE IMAGE PROCESSOR CIRCUIT BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM WOULD DISPLAY A BLACK SCREEN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |