FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2982102
·
Received February 8, 2013
Report
- Report Number
- 1720753-2013-01595
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- January 23, 2013
- Report Date
- February 8, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SINGLE BOARD COMPUTER AND THE IMAGE PROCESSOR WERE REPLACED 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 WHEN THE SCREENS ARE TURNED ON THERE IS A NO SIGNAL INPUT MESSAGE ON SCREEN. IT IS LIKELY THAT THE SYSTEM FAILED TO DISPLAY AN IMAGE ON BOTH MONITORS. THERE WAS NO PT INJURY OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55269 | 9800 | FLUOROSCOPY X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |