FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2181547
·
Received July 7, 2011
Report
- Report Number
- 1720753-2011-08831
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 28, 2011
- Report Date
- July 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD WAS REPLACED AND THE CALIBRATION FILES WERE RELOADED. 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 CHANNEL 8 AND CHANNEL 15 ERROR MESSAGES AND WOULD NOT BOOT UP. THE CASE WAS COMPLETED WITH ANOTHER SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |