FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1083763
·
Received July 29, 2008
Report
- Report Number
- 1720753-2008-24120
- Event Type
- Malfunction
- Date Received
- July 29, 2008
- Date of Event
- July 22, 2008
- Report Date
- July 29, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE COLLIMATOR IRIS POT ERROR APPEARED ON THE MAINFRAME DISPLAY DURING SYSTEM BOOT-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 |