FDA Adverse Event
Malfunction
Summary report: N
OEC 9800
MDR report key: 1719961
·
Received October 16, 2009
Report
- Report Number
- 1720753-2009-07578
- Event Type
- Malfunction
- Date Received
- October 16, 2009
- Date of Event
- October 1, 2009
- Report Date
- October 15, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE X-RAY DISABLE KEY WAS NOT TURNED TO THE CORRECT POSITION FOR VERTICAL MOVEMENT. SYSTEM OPERATES AS INTENDED. (B) (4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VERTICAL COLUMN WILL NOT MOVE UP OR DOWN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OEC 9800 | SURGICAL NAVIGATION SYSTEM | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |