EASYSUITE 4K-1220, IN-ROOM

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM THAT UPON FURTHER REVIEW, THE RISK ASSESSMENT FOR THE REPORTED FAILURE MODE HAS BEEN REVISED. PER THE LEGAL MANUFACTURER, THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

Additional Manufacturer Narrative

THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE MONITORS AND TOUCH PANEL OF THE EASY SUITE 4K IN-ROOM SYSTEM FLICKER WHEN USING MONOPOLAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.