FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2041408
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02657
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE 6800 SYSTEM BATTERY VOLTAGE WAS CHECKED AND THE PRINTED CIRCUIT BOARDS WERE RESEATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 6800 SYSTEM WOULD NOT BOOT UP AND PRODUCED AN ERROR CODE. 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 |