FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1260810
·
Received December 12, 2008
Report
- Report Number
- 1720753-2008-21820
- Event Type
- Malfunction
- Date Received
- December 12, 2008
- Date of Event
- May 9, 2008
- Report Date
- May 21, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE FLUORO MONITOR ON THE DUAL FLAT PANEL DISPLAY WAS BLINKING. PTS HAD ALL BEEN COMPLETED AND NO PTS WERE INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |