FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2278659
·
Received September 22, 2011
Report
- Report Number
- 1720753-2011-22233
- Event Type
- Malfunction
- Date Received
- September 22, 2011
- Date of Event
- September 16, 2011
- Report Date
- September 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE RETRIEVED THE ERROR LOG FILES AND CHECKED THE (B)(4) POWER SUPPLY AND INSPECTED AND REASSEMBLED THE INTERCONNECT CABLE PLUG AND THE JACK AND CHECKED THE WIRING BETWEEN THE CAMERA AND THE VIDEO CONTROLLER AND RESEATED THE VIDEO CONTROLLER SYSTEM INTERFACE AND THE GENERATOR INTERFACE AND THE FLUORO FUNCTIONS PRINTED CIRCUIT BOARDS AND THE REBUILT THE FFD AND THE GIB FLASH MEMORY AS WELL AS RELOADED THE CALIBRATION FILES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A COMMUNICATION ERROR MESSAGE. 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 |