FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2042286
·
Received February 15, 2011
Report
- Report Number
- 9680959-2011-00766
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 17, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTANT PERFORMED AN ONSITE INVESTIGATION. A FUSE WAS REPLACED IN THE MONITOR AND IN THE GENERATOR. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT TWO FUSES HAD BLOWN IN THE 7900 SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |