FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2191546
·
Received July 27, 2011
Report
- Report Number
- 1720753-2011-20483
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- July 20, 2011
- Report Date
- July 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP RETRIEVED THE ERROR LOG FILES, AND CHECKED THE VIDEO AND PILOT CABLE RESISTANCE, AND THE CONNECTIONS AS WELL AS CHECKED THE BATTERY VOLTAGE. 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 BLANK SCREEN DURING FLUOROSCOPIC X-RAY. 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 |