FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1183016
·
Received October 3, 2008
Report
- Report Number
- 1720753-2008-25051
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 25, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM WAS REPAIRED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED POOR IMAGE QUALITY. ALSO THEY MUST RE-BOOT THE SYSTEM SEVERAL TIMES BEFORE IT COMES UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |