FDA Adverse Event
Malfunction
Summary report: N
GE OEC 6800
MDR report key: 1191422
·
Received October 9, 2008
Report
- Report Number
- 1720453-2008-25305
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- August 4, 2008
- Report Date
- September 2, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED, AND FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SVC.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 6800 SYSTEM HAD NO IMAGE DURING A CASE. THE 6800 SYSTEM HAD TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |