FDA Adverse Event
Injury
Summary report: N
GE OEC 2800
MDR report key: 1581198
·
Received January 14, 2010
Report
- Report Number
- 1720753-2010-00113
- Event Type
- Injury
- Date Received
- January 14, 2010
- Date of Event
- June 14, 2006
- Report Date
- January 14, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IN 2006, THE GE SERVICE REPRESENTATIVE TIGHTENED HARDWARE AND LUBRICATED THE LEG EXTENSION FOR EASE OF OPERATION. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED.
Description of Event or Problem · 1
IN 2009, GE OEC WAS NOTIFIED OF AN INCIDENT INVOLVING A 2800 UROVIEW TABLE BY OUR LEGAL COUNSEL. THE INCIDENT ALLEGED THAT AN OPERATING ROOM NURSE SUSTAINED A CERVICAL HERNIATION WHILE MOVING THE UROLOGY TABLE OR SOME PART OF THE TABLE IN 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |