FDA Adverse Event
Malfunction
Summary report: N
GE OEC 6800
MDR report key: 1435074
·
Received May 15, 2009
Report
- Report Number
- 1720753-2009-03804
- Event Type
- Malfunction
- Date Received
- May 15, 2009
- Date of Event
- April 24, 2009
- Report Date
- May 15, 2009
- Manufacturer
- GE OEC MEDICAL INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE 5V POWER SUPPLY. SYSTEM OPERATES AS INTENDED. (B) (4).
Description of Event or Problem · 1
CUSTOMER REPORTED AN INTERMITTENT "SYSTEM NOT OPERATIONAL" MESSAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 6800 | FLUOROSCOPIC X-RAY SYSTEM | JAA | GE OEC MEDICAL INC. | 6800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |