FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2101659
·
Received May 11, 2011
Report
- Report Number
- 9617766-2011-01032
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 25, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD
- 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 ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE CELERON PROCESSOR AND THE HARD DRIVE, AND RELOADED THE SOFTWARE. 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 WOULD NOT DISPLAY AN IMAGE ON EITHER MONITOR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MED SYSTEMS (INDIA) PRIVATE LTD | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |