FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1070300
·
Received July 9, 2008
Report
- Report Number
- 1720753-2008-20531
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 9, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEM INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE GENERATOR INTERFACE BOARD, ALSO DETERMINED POWER PROBLEM IS ONLY IN O.R. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED, THE SYSTEM IS HAVING POWER ISSUES. NO PT 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 SYSTEM INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |