FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 2181014
·
Received July 7, 2011
Report
- Report Number
- 1720753-2011-08805
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 22, 2011
- Report Date
- July 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE CMOS BATTERY, AND THE X-RAY SWITCH, AND CHECKED THE VOLTAGES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD LOCK UP AND CONTINUE TO PRODUCE FLUOROSCOPIC X-RAY BEYOND DEMAND. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |