FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2201308
·
Received August 3, 2011
Report
- Report Number
- 1720753-2011-20647
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 21, 2011
- Report Date
- August 3, 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 REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR INTERFACE BOARD, FLUORO FUNCTIONS BOARD, INTERCONNECT CABLE, CLOSED CIRCUIT DIGITAL CAMERA AND THE VIDEO CONTROLLER WERE ALL REPLACED. THE FILAMENT AND GENERATOR WERE CALIBRATED AND THE SOFTWARE WAS UPGRADED. 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 AN X-RAY DISABLED ERROR AND WAS UNABLE TO FLUORO. 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 |