FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2193207
·
Received July 21, 2011
Report
- Report Number
- 1720753-2011-20274
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MILLIAMPERE FILAMENT DUTY CYCLE WAS CALIBRATED. 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 THE SYSTEM DISPLAYED A LOW MILLIAMPERE ERROR MESSAGE DUE TO TUBE FILAMENT AGING PARAMETERS MISMATCH, AND THERE WAS NO IMAGE ON THE SCREEN. 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 |