FDA Adverse Event
Malfunction
Summary report: N
GE OEC 2600
MDR report key: 1002690
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16419
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYS AND PERFORMED THE NECESSARY ALIGNMENTS. SYS OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT FLUORO IMAGE IN NORMAL MAG MODE IS 10 6/8THS" VICE 11 2/8THS" OEC MINIMUM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |