FDA Adverse Event
Malfunction
Summary report: N
FLUOROSTAR
MDR report key: 1220652
·
Received October 31, 2008
Report
- Report Number
- 9680959-2008-00203
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 29, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP CHANGED THE LEFT AND RIGHT USER INTERFACE. HE ALSO COMPLETED A SOFTWARE UPGRADE. HE ALSO CHECKED THE CONNECTION CABLES BETWEEN THE USER INTERFACE AND THE IPC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE LEFT AND RIGHT USER INTERFACE INTERMITTENTLY IS DARK DURING A BOOT UP PROCEDURE. IT PERIODICALLY JITTERS AND IS NOT OPERABLE. IF THE RIGHT INTERFACE DOESN'T BOOT UP NEVERTHELESS IT IS POSSIBLE TO OPERATE THE LEFT USER INTERFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSTAR | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |