FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2940905
·
Received January 16, 2013
Report
- Report Number
- 1720753-2013-00727
- Event Type
- Malfunction
- Date Received
- January 16, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 16, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE HIGH VOLTAGE CABLE WAS CLEANED AND REGREASED AND THE FILAMENT WAS CALIBRATED DURING THE SVC CALL. THE SYS 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 FROZE, THE SCREEN WENT BLACK, AND THEY HEARD A POPPING NOISE. THESE ISSUES COULD CAUSE THE SYS TO BECOME UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24890 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |