FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2160410
·
Received June 20, 2011
Report
- Report Number
- 1720753-2011-08288
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PREFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REFORMATTED THE HARD DRIVE AND RELOADED THE SOFTWARE AS WELL AS REBUILT THE NODE. 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 SYSTEM WOULD NOT BOOT UP. 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 |