FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1952172
·
Received January 4, 2011
Report
- Report Number
- 1720753-2011-00015
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 14, 2010
- Report Date
- January 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BACKPLANE AND THE SINGLE BOARD COMPUTER UPGRADE KIT WERE INSTALLED 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 HAD NO DISPLAY ON EITHER MONITOR WITH INTERMITTENT LINES IN THE LEFT MONITOR DURING A CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. 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 |