FDA Adverse Event
Malfunction
Summary report: N
OEC 8800
MDR report key: 1593175
·
Received January 27, 2010
Report
- Report Number
- 9617766-2010-00037
- Event Type
- Malfunction
- Date Received
- January 27, 2010
- Date of Event
- December 16, 2009
- Report Date
- January 27, 2010
- Manufacturer
- GE BE MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE HAS NOT REPORTED AN EVALUATION OF THE EQUIPMENT. (B) (4). THIS MDR WAS ORIGINALLY FILED WITH THE INCORRECT REPORT NUMBER OF 9617766-2010-00028 ON 01/20/2010.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT IRIS COLLIMATION IS FAILING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OEC 8800 | SURGICAL NAVIGATION SYSTEM | JAA | GE BE MEDICAL SYSTEMS INC. | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |