FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1973615
·
Received January 19, 2011
Report
- Report Number
- 1720753-2011-00390
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 19, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE BOARDS AND CONNECTORS WERE RESEATED 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 9900 SYS HAD AN INTERMITTENT FAST STOP ERROR DURING A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |