FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2850492
·
Received November 27, 2012
Report
- Report Number
- 1720753-2012-09716
- Event Type
- Malfunction
- Date Received
- November 27, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 27, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HEAT SENSOR WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HEAT SENSOR WAS REPLACED 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
THE CUSTOMER REPORTED AN ERROR MESSAGE HOUSING WARM AND DISABLED. THE FSE REPORTED ANODE HOUSING HEAT AT 99% AT BOOT UP. THIS ERROR MESSAGE WILL RESULT IN A LOSS OF X-RAY FUNCTIONALITY. THERE IS NO REPORT OF INJURY OF DEATH ASSOCIATED WITH THIS EVENT.
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 |