FDA Adverse Event
Malfunction
Summary report: N
GE OEC 6600
MDR report key: 1011783
·
Received March 11, 2008
Report
- Report Number
- 1720753-2008-17875
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 7, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND DETERMINED THE X-RAY TUBE WAS BAD. PART IS ON ORDER. IT IS ANTICIPATED THAT RECEIPT AND INSTALLATION OF THIS PART WILL RESTORE THE SYSTEM TO OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED A CRESCENT SHAPED DEFECT IN IMAGES AND POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 6600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |