FDA Adverse Event
Malfunction
Summary report: N
GE OEC 6800
MDR report key: 1152931
·
Received September 10, 2008
Report
- Report Number
- 1720753-2008-22248
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 26, 2008
- Report Date
- June 6, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE RIGHT MONITOR. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED POOR IMAGE QUALITY AND A HIGH FREQUENCY NOISE COMING FROM THE MONITOR. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 6800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |