FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2837776
·
Received November 7, 2012
Report
- Report Number
- 1720753-2012-09183
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Date of Event
- October 30, 2012
- Report Date
- November 7, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VIDEO CONTROLLER BOARD WAS RESEATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A FLUOROSCOPIC IMAGE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |