FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 1992837
·
Received February 4, 2011
Report
- Report Number
- 9680959-2011-00268
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS SYSTEM REPAIR AND REPLACEMENT INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORTS OF PATIENT OR STAFF INJURY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM'S LEFT MONITOR FAILED TO DISPLAY AN IMAGE. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |