FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9600
MDR report key: 1315130
·
Received February 19, 2009
Report
- Report Number
- 1720753-2008-27701
- Event Type
- Malfunction
- Date Received
- February 19, 2009
- Date of Event
- October 16, 2008
- Report Date
- November 3, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE ANALOG INTERFACE, X-RAY REGULATOR, AND GENERATOR DRIVER BOARDS. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED A REGULATOR ERROR AFTER EACH SHOT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |