FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2041602
·
Received March 24, 2011
Report
- Report Number
- 9680959-2011-00863
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- February 24, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MONITOR AND CABLES WERE CHECKED. THE CAMERA NEEDS TO BE REPLACED. NO CONCLUSION CAN BE DRAWN AS THE REPAIR INFO IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS NO IMAGE ON THE 7700 SYSTEM. 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 |