FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2042310
·
Received February 15, 2011
Report
- Report Number
- 9680959-2011-00761
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 14, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 7700 SYSTEM WOULD NOT PRODUCE X-RAYS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |