FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2223042
·
Received August 10, 2011
Report
- Report Number
- 1720753-2011-20893
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP CHECKED THE ERROR LOG FILES AND THE MAINFRAME 5VDC POWER SUPPLY AND THE X-RAY SWITCH AS WELL AS RESEATED THE X-RAY CONTROLLER PRINTED CIRCUIT BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY AN EMERGENCY STOP SWITCH ERROR MESSAGE AND PRODUCE SUBTRACTED IMAGES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |