FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2191460
·
Received June 7, 2011
Report
- Report Number
- 9680959-2011-01369
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- May 27, 2011
- Report Date
- June 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECTION POWER CABLE WAS TIGHTENED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT HAND MONITOR WAS FADING IN AND OUT AND THE PROBLEM SEEMED TO BE RELATED TO THE CONNECTION OF THE IMAGE INTENSIFIER AND THE MONITOR CART POWER CABLE. 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 |