FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2171009
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08657
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 30, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SVC REP CONDUCTED AN ONSITE INVESTIGATION. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE POWER CORD AND VIDEO CABLE WERE CHECKED. THE POWER SUPPLY WAS ADJUSTED. THE FLASH MEMORY WAS ERASED AND RELOADED. THE HARD DRIVE WAS REFORMATTED AND THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT BOTH MONITORS ON THE SYSTEM WOULD GO BLACK. 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 |