FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1232523
·
Received November 13, 2008
Report
- Report Number
- 1720753-2008-28063
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 17, 2008
- Report Date
- November 13, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP RELOADED THE SOFTWARE AND ALL CAL FILES. HE TESTED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED ISSUE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE PLAYBACK OF THE SUBTRACTION RUNS WERE BLACKED OUT OR DOUBLE OVERLAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |