FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2073683
·
Received April 13, 2011
Report
- Report Number
- 1720753-2011-03559
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 13, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE SINGLE BOARD COMPUTER AND THE IMAGE PROCESSOR BOARD WAS REPLACED. THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 6800 SYSTEM WOULD NOT BOOT UP. 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 |