FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2193137
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20309
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SUNDANCE UPGRADE KIT, THE GENERATOR INTERFACE BOARD, AND THE VIDEO CONTROLLER WERE INSTALLED. THE SOFTWARE AND CALIBRATION FILES WERE RELOADED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYS DISPLAYED A BLACK SCREEN. THE CASE WAS COMPLETED WITH ANOTHER SYS. 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 |