FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2101792
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07132
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 22, 2011
- Report Date
- May 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP REPLACED THE WORKSTATION BACKPLANE, THE SINGLE BOARD COMPUTER BOARD KIT, THE IMAGE PROCESSOR, THE DISPLAY ADAPTER, THE VIDEO CONTROLLER, THE GENERATOR INTERFACE BOARD, THE FLUORO FUNCTIONS BOARD, AND THE MAINTENANCE BACKPLANE. THE SVC REP ALSO REPLACED THE WORKSTATION ON OFF SWITCH AND LOADED THE SOFTWARE AND CALIBRATION FILES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN IMAGE PROCESSING BOARD FAILURE ERROR MESSAGE. 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 |