FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2823639
·
Received September 25, 2009
Report
- Report Number
- 1720753-2009-07126
- Event Type
- Malfunction
- Date Received
- September 25, 2009
- Date of Event
- September 15, 2009
- Report Date
- September 24, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY SYSTEM | JAA | GE OEC MEDICAL SYSTEMS INC. | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |