MalfunctionJJA
GE OEC 9800
Received May 10, 2007 · Event occurred Apr 10, 2007
Report 1720753-2007-00634 · MDR key 962219
Device
Generic name
Fluoroscopic X-ray
Manufacturer
Ge Oec Medical Systems Inc.Model number
GE OEC 9800Catalog number
NA
Lot number
NA
Product problems
- Device Inoperable
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE GE OEC 9800 FLUOROSCOPY SYSTEM HAD A "PRE-CHARGE FAILURE ERROR" MESSAGE DISPLAYED AND THE SYSTEM WAS THEN INOPERABLE.
Additional Manufacturer Narrative
A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND A CONNECTOR INSIDE THE REMOTE USER INTERFACE THAT NEEDED TO BE REPAIRED. THE SERVICE REPRESENTATIVE REPAIRED THE CONNECTION, TESTED THE RUI AND FOUND IT TO BE WORKING AS INTENDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT DUE TO THIS SYSTEM MALFUNCTION. THE SYSTEM WAS RELEASED TO THE CUSTOMER FOR USE.
Remedial action
- Repair