FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1980046
·
Received January 24, 2011
Report
- Report Number
- 1720753-2011-00518
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- December 30, 2010
- Report Date
- January 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE VERTICAL LIFT BUTTON WAS CORRECTED BY THE CUSTOMER. THE VIDEO MONITOR CABLE CONNECTION WAS REPAIRED DURING THE SERVICE CALL. THE SYSTEM WAS 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 A VERTICAL LIFT COLUMN BUTTON ISSUE AND THE IMAGE INTERMITTENTLY BLANKS OUT. 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 |