FDA Adverse Event
Malfunction
Summary report: N
GE OCE 2800
MDR report key: 867298
·
Received June 19, 2007
Report
- Report Number
- 1720753-2007-02249
- Event Type
- Malfunction
- Date Received
- June 19, 2007
- Date of Event
- May 23, 2007
- Report Date
- June 19, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REP INVESTIGATED THE ISSUE AND FOUND A DEFECTIVE SURGE SUPPRESSOR PCB THAT WAS REMOVED AND REPLACED TO REPAIR THE MALFUNCTION. THE SYSTEM WAS TESTED AND FOUND TO BE OPERATING AS INTENDED, AND WAS RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE.
Description of Event or Problem · 1
THE GE OEC 2800 FLUOROSCOPY SYSTEM WOULD NOT BOOT UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OCE 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | GE OEC 2800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |