FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2801418
·
Received October 18, 2012
Report
- Report Number
- 9680959-2012-01319
- Event Type
- Malfunction
- Date Received
- October 18, 2012
- Date of Event
- September 18, 2012
- Report Date
- October 18, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. THERE WAS NO PT INJURY OR DEATH 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 |