FDA Adverse Event
Malfunction
Summary report: N
GE OEC 7700
MDR report key: 1152389
·
Received September 10, 2008
Report
- Report Number
- 9680959-2008-00099
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 17, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A F/U REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 7700 SYSTEM WOULD NOT SAVE IMAGES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 7700 | FLUOROSCOPOC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |