FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2152183
·
Received June 23, 2011
Report
- Report Number
- 9680959-2011-01489
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CABLE WAS ORDERED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY AN IMAGE AND THERE WAS JUST A SQUARE ON THE FLUOROSCOPY SCREEN. THE X-RAYS WERE GETTING THROUGH AND WHEN THE CABLE WAS MOVED THE ISSUE DISAPPEARED. NO PATIENT 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 |