FDA Adverse Event
Malfunction
Summary report: N
7600
MDR report key: 2241256
·
Received August 17, 2011
Report
- Report Number
- 9680959-2011-09853
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- January 24, 2008
- Report Date
- August 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ON SITE EVAL. THE REP CHECKED THE VIDEO CARD CONNECTIONS. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. DURING A RETROSPECTIVE REVIEW THIS EVENT WAS DETERMINED TO BE REPORTABLE. IT WAS INCLUDED AS PART OF A RETROSPECTIVE SUMMARY REPORT (RSR) REQUEST TO FDA ON APRIL 26, 2011 (B)(4). FDA REQUESTED THIS EVENT TO BE REMOVED FROM THE RSR REQUEST AND FILED VIA 3500A.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT MONITOR SHUTS OFF. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |