FDA Adverse Event
Injury
Summary report: N
GE OEC 6800
MDR report key: 1033115
·
Received April 23, 2008
Report
- Report Number
- 1720753-2008-20843
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 22, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYS AND COULD NOT REPRODUCE THE REPORTED PROBLEM. SYS OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYS WILL NOT BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC | 6800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |