FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3000945
·
Received February 27, 2013
Report
- Report Number
- 1720753-2013-03191
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 27, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN IN SITE INVESTIGATION. THE BACKPLANE, FLUORO FUNCTIONS BOARD, GENERATOR INTERFACE BOARD, SYSTEM INTERFACE BOARD, CPU, AND THE INTERCONNECT CABLE WERE 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 THAT THEY SYSTEM WOULD NOT BOOT UP. THERE WAS NO PT INJURY OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83586 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |