OR INTEGRATION SYSTEM
Received Sep 4, 2014 · Event occurred Aug 5, 2014
Report 1000404456-2014-00005 · MDR key 4061466
Device
Generic name
Integration System
Manufacturer
Vts Medical Systems, LlcProduct problems
- No Display/Image
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THE SURGICAL MONITORS BLANKED OUT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO INJURIES WERE REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND DETERMINED THAT THE FIBER INPUT TO THE MONITOR AND ITS ASSOCIATED FIBER CONNECTION MODULE WERE NOT OPERATING PROPERLY, CAUSING THE IMAGE TO DROP OUT AT THE MONITOR. THE TECHNICIAN REPLACED THE MONITOR, WHICH RESOLVED THE ISSUE. THE MONITOR SUBJECT OF THIS EVENT WAS SENT BACK TO STERIS FOR EVALUATION. THE MONITOR WAS EVALUATED HOWEVER THE REPORTED EVENT COULD NOT BE DUPLICATED.