FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2100854
·
Received May 12, 2011
Report
- Report Number
- 9680959-2011-01230
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 12, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE IMAGE PROCESSOR CPU. THE INTERFACE CABLE NEEDS TO BE REPLACED. THE CABLE WAS PLACED ON ORDER. IT IS ANTICIPATED THAT REPLACEMENT OF THIS CABLE WILL RESTORE THE SYSTEM TO OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WOULD NOT TAKE EXPOSURES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |