FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1993242
·
Received February 7, 2011
Report
- Report Number
- 1720753-2011-01056
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 23, 2011
- Report Date
- February 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE SINGLE BOARD COMPUTER, REPLACED THE HARD DRIVE, REPLACED THE IMAGE PROCESSOR CIRCUIT BOARD, AND RELOADED SOFTWARE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WILL NOT BOOT UP, OR WILL INTERMITTENTLY BOOT UP IN MAG (MAGNIFIED) MODE.
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 |