FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2043006
·
Received March 25, 2011
Report
- Report Number
- 9680959-2011-00873
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- December 29, 2010
- 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
THE GE REP CONDUCTED AN ON SITE INVESTIGATION. THE SERVICE REP REPLACED AND CALIBRATED THE IMAGE PROCESSOR COMPUTER AND RELOADED THE SOFTWARE. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A CAMERA FAILURE ERROR MESSAGE WAS DISPLAYED 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 |