FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1980056
·
Received January 24, 2011
Report
- Report Number
- 1720753-2011-00501
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION AND INSTALLED A SBC REPAIR KIT, LOADED RELEASE 10 SOFTWARE AND CALIBRATION FILES. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 6800 SYSTEM HAS BOOT UP ISSUES FROM THE HARD DRIVE. 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 |