FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1992759
·
Received February 4, 2011
Report
- Report Number
- 1720753-2011-00881
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 13, 2011
- Report Date
- February 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED AND THE GENERATOR AND FILAMENT WERE CALIBRATED 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 9800 SYSTEM MADE A POPPING NOISE AND THE SCREEN WENT BLACK DURING A CASE. THE PROCEDURE WAS COMPLETED. 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 |