FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3801737
·
Received February 11, 2014
Report
- Report Number
- 1720753-2014-01384
- Event Type
- Malfunction
- Date Received
- February 11, 2014
- Date of Event
- February 1, 2014
- Report Date
- February 11, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE VIDEO CONTROL BOARD, IMAGE PROCESSOR BOARD AND DISPLAY ADAPTOR BOARD WERE EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LEFT (LIVE) MONITOR FAILED TO DISPLAY FLUOROSCOPIC IMAGE. THE ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88859 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |