FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 2152631
·
Received June 27, 2011
Report
- Report Number
- 1720753-2011-08529
- Event Type
- Malfunction
- Date Received
- June 27, 2011
- Date of Event
- April 18, 2011
- Report Date
- June 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE ROM CHIP U25 ON THE IMAGE PROCESSOR WAS REPLACED, AND THE HARD DISK DRIVE AND THE MOTHERBOARD WERE REPLACED. 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 LOST DATA. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |