FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2191186
·
Received July 19, 2011
Report
- Report Number
- 1720753-2011-20184
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 19, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- 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 REP PERFORMED AN ON SITE INVESTIGATION. THE SRAM CARD IN THE C-ARM MAINFRAME WAS REPLACED AND THE CONFIGURATION FILES WERE RESET. 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 THE SYSTEM WOULD NOT BOOT UP AND REPLACEMENT OF THE GENERATOR AND SOFTWARE WAS NEEDED. 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 |