FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1013905
·
Received March 18, 2008
Report
- Report Number
- 1720753-2008-16525
- Event Type
- Malfunction
- Date Received
- March 18, 2008
- Date of Event
- February 22, 2008
- Report Date
- February 29, 2008
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE, FOUND NO VIDEO FROM THE CCD CAMERA, AND REMOVED AND REPLACED THE FAULTY CCD CAMERS. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
GE OEC 9800 WITH REPORTED: FOUND NO VIDEO ON CCD CAMERA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | X-RAY C-ARM | JAA | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |