FDA Adverse Event
Malfunction
Summary report: N
GE OEC 2800 UROVIEW
MDR report key: 857637
·
Received May 31, 2007
Report
- Report Number
- 1720753-2007-01438
- Event Type
- Malfunction
- Date Received
- May 31, 2007
- Date of Event
- May 2, 2007
- Report Date
- May 31, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REPRESENTATIVE WAS INVESTIGATING THE ISSUE AND REPLACED SINGLE BOARD COMPUTER, REPLACED THE EMO SWITCH AND RE-SEATED ALL OTHER PCBS AND FLASHED THE NODES. THE SYSTEM WAS TESTED AND FOUND TO BE OPERATING AS INTENDED. NO NEGATIVE PT EFFECT WAS CAUSED BY THIS MALFUNCTION. THE FACILITY WAS UNABLE OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE.
Description of Event or Problem · 1
THE GE OEC 2800 UROVIEW FLUOROSCOPY SYSTEM DISPLAYED A COMMUNICATION FAILURE ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 2800 UROVIEW | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | GE OEC 2800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |