FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2062914
·
Received March 21, 2011
Report
- Report Number
- 1720753-2011-02546
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 23, 2011
- Report Date
- March 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE RIGHT MONITOR AND HARD DRIVE WAS REPLACED AND THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 6800 SYSTEM WOULD NOT BOOT UP AND THAT THE RIGHT MONITOR WAS BURNT IN. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |