FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2043038
·
Received March 25, 2011
Report
- Report Number
- 9680959-2011-00874
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- January 3, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A GENERATOR ERROR ON THE 7900 SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |