FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1021731
·
Received March 19, 2008
Report
- Report Number
- 1720753-2008-19751
- Event Type
- Malfunction
- Date Received
- March 19, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD, PS1 AND PS3 POWER SUPPLIES WERE 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 COLLIMATOR CLOSED DOWN AND LOCKED UP DURING A CASE ON THE 9800 SYSTEM. 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 |