FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2030588
·
Received March 9, 2011
Report
- Report Number
- 9680959-2011-00721
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 9, 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 REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. A FUSE WAS REPLACED IN THE MONITOR AND THE VOLTAGE IN THE INPUT TRANSFORMER WAS ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITORS OF THE 7700 SYSTEM WOULD NOT TURN ON. 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 |