FDA Adverse Event
Malfunction
Summary report: N
GE OEC FLUOROSTAR
MDR report key: 1446769
·
Received August 24, 2009
Report
- Report Number
- 9680959-2009-00130
- Event Type
- Malfunction
- Date Received
- August 24, 2009
- Date of Event
- May 29, 2009
- Report Date
- June 4, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM, AND REPAIRED THE PEAR SWITCH. NO REPORT ON SYSTEM REPAIR STATUS OR REPAIRS ON OTHER PROBLEMS REPORTED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BROKEN HANDLES AND SWITCHES, AND THE BUNG IS JAMMED ON THE ARCH BASE OUTLET. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC FLUOROSTAR | FLUOROSCOPIC X-RAY SYSTEM | JAA | GE OEC MEDICAL SYSTEMS INC. | 7700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |