FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1031004
·
Received April 17, 2008
Report
- Report Number
- 1720753-2008-20647
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 14, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THE FILAMENT DRIVER BOARD WAS NOT THE PROBLEM. GE REP REPLACED THE HIGH VOLTAGE TANK AND SNUBBER BOARD. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM'S FILAMENT DRIVER BOARD HAS FAILED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |