FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2201370
·
Received August 3, 2011
Report
- Report Number
- 1720753-2011-20676
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 3, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INPUT TRANSFORMER'S VOLTAGE WAS ADJUSTED AND ALL THE INNER TRANSFORMER NUTS WERE TIGHTENED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYSTEM DISPLAYED AN ERROR MESSAGE. THE CASE WAS COMPLETED AND 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 |