FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2170999
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08659
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 30, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP FLASHED THE NODES, FORMATTED THE HARD DRIVE, AND RELOADED THE SOFTWARE AND THE CALIBRATION FILES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD TAKE A LONG TIME TO 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 |