FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1172986
·
Received September 19, 2008
Report
- Report Number
- 1720753-2008-26087
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 29, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. CUSTOMER WAS TESTING GENERATORS AT THE TIME OF THE PROBLEM OCCURRENCE. SUSPECT FAULTY BOOTS WERE CAUSED BY POWER FLUCTUATIONS. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED BOTH MONITORS WENT DIM DURING A CASE. 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 |