FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2171366
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08661
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 30, 2011
- 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 REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE KEYBOARD CONTROL BOARD, THE INTERCONNECT CABLE, AND THE FLUORO FUNCTIONS BOARD, AS WELL AS RECALIBRATED THE MAGNIFICATION AND THE FOCUS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP, AND THE KEYBOARD MADE A NOISE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |