FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1910029
·
Received November 10, 2010
Report
- Report Number
- 1720753-2010-04027
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 21, 2010
- Report Date
- November 10, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE TEMPERATURE SENSOR WAS REPLACED AND THE HIGH VOLTAGE CABLE WAS CLEANED AND DEGREASED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEM WAS ARCING AND HAD A TEMPERATURE SENSOR ERROR DURING A CASE. THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |