FDA Adverse Event
Malfunction
Summary report: N
GE OEC 2600
MDR report key: 1356550
·
Received April 8, 2009
Report
- Report Number
- 1720753-2009-00277
- Event Type
- Malfunction
- Date Received
- April 8, 2009
- Date of Event
- December 15, 2008
- Report Date
- January 9, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM, AND ADJUSTED THE MICROSWITCHES AND RELUBRICATED THE DRIVE RAILS. SYSTEM OPERATES AS INTENDED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.
Description of Event or Problem · 1
CUSTOMER REPORTED A FILMER STUCK MESSAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 2600 | FLUOROSCOPIC X-RAY SYSTEM | JAA | GE OEC MEDICAL SYSTEMS INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |