HARMONY IQ 2800 INTEGRATION SYSTEM
Received Feb 6, 2015 · Event occurred Jan 7, 2015
Report 1000404456-2015-00002 · MDR key 4501322
Device
Generic name
Integration System
Manufacturer
Vts Medical Systems, Inc.Product problems
- Material Distortion
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED COLOR DISTORTION AND STATIC LINES ON THEIR VIVIDIMAGE PRO MONITORS. THE FACILITY CONTACTED STERIS SUPPORT IN AN ATTEMPT TO RESOLVE THE REPORTED ISSUE; HOWEVER, THE COLOR DISTORTION AND STATIC LINES REMAINED. A PROCEDURAL DELAY WAS REPORTED DUE TO THE EVENT.
Additional Manufacturer Narrative
INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.
Additional Manufacturer Narrative
A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY, INSPECTED AND TESTED THE INTEGRATION SYSTEM AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE TECHNICIAN PERFORMED THE NECESSARY REPAIRS INCLUDING REPLACEMENT OF THE VIVIDIMAGE PRO MONITORS, TESTED THE SYSTEM AND PLACED IT BACK INTO SERVICE.