FDA Adverse Event
Malfunction
Summary report: N
GE OEC FLUOROSTAR
MDR report key: 1003325
·
Received February 27, 2008
Report
- Report Number
- 9680959-2008-00032
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- January 31, 2008
- Report Date
- February 27, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE FUSES. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM BLEW FUSES AS LIFT COLUMN WAS MOVING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC FLUOROSTAR | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | FLUOROSTAR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |