FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1001300
·
Received February 22, 2008
Report
- Report Number
- 1720753-2008-16356
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- February 14, 2008
- Report Date
- February 21, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYS AND COULD NOT DUPLICATE THE REPORTED PROBLEM. GE REP PERFORMED VARIOUS ALIGNMENTS AND CALIBRATIONS AS PREVENTATIVE MEASURES. SYS OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED AN IMAGE QUALITY ISSUE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |