FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1961148
·
Received January 11, 2011
Report
- Report Number
- 1720753-2011-00141
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- September 17, 2008
- Report Date
- January 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE PRINTER CIRCUIT BOARD, DISPLAY ADAPTER, AND SINGLE BOARD COMPUTER WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED DISTORTED IMAGES AND FAILED TO BOOT UP. NO REPORT OF PATIENT INJURY.
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 |