FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2160412
·
Received June 20, 2011
Report
- Report Number
- 1720753-2011-08293
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE SRAM CARD AND PERFORMED THE PROFILE SETUP. 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 NOT PERFORM FLUOROSCOPIC X-RAY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |