FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1001255
·
Received February 22, 2008
Report
- Report Number
- 1720753-2008-16370
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- February 14, 2008
- Report Date
- February 22, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE CINE BRIDGE BOARD, CINE DRIVE, AND HARD DRIVE WERE REPLACED AND THE SOFTWARE WAS RE-INSTALLED DURING THE SVC CALL. THE SYS 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 CINE RUN ON THE 9800 SYS WOULD NOT PLAY BACK DURING A CASE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PT 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. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |