HARMONY IQ 3600 INTEGRATION SYSTEM
Received Aug 22, 2014 · Event occurred Jul 24, 2014
Report 1000404456-2014-00004 · MDR key 4031420
Device
Generic name
Harmony Iq
Manufacturer
Vts Medical Systems, LlcProduct problems
- Application Interface Becomes Non-Functional Or Program Exits Abnormally
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT THEIR TOUCH PANEL FROZE WHILE ROUTING IMAGES DURING A PATIENT PROCEDURE.
Additional Manufacturer Narrative
THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN EVALUATED THE SYSTEM AND WAS ABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN MADE THE NECESSARY REPAIRS AND RETURNED THE SYSTEM TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.