HARMONY IQ 3600 INTEGRATION SYSTEM
Received Sep 26, 2014 · Event occurred Sep 4, 2014
Report 1000404456-2014-00008 · MDR key 4122291
Device
Generic name
Integration System
Manufacturer
Vts Medical SystemsProduct problems
- No Display/Image
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE MONITOR BLANKED OUT AND CONTINUED TO BLINK DURING THE CASE. A REPLACEMENT MONITOR WAS BROUGHT INTO THE ROOM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURIES WERE REPORTED.
Additional Manufacturer Narrative
A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY, INSPECTED THE INTEGRATION SYSTEM AND DETERMINED THE ISSUE WAS CAUSED BY THE CAMERA UTILIZED AT THE TIME OF THE EVENT. THE TECHNICIAN MADE THE NECESSARY ADJUSTMENTS, TESTED THE INTEGRATION SYSTEM AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION.
Additional Manufacturer Narrative
THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.