FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2023516
·
Received March 1, 2011
Report
- Report Number
- 9680959-2011-00612
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- December 8, 2010
- Report Date
- March 1, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE IMAGE PROCESSING COMPUTER. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 7900 SYSTEM FAILED TO BOOT UP. 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 |