EASYSUITE 4K INTEGRATION SYS MODEL 1200

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS TO PROVIDE A CORRECTION TO THE INITIAL MEDWATCH REPORT (MDR). FURTHER REVIEW FOUND THERE WAS NO REPORTABLE MALFUNCTION RELATED TO THE SUBJECT DEVICE CAPTURED IN THIS COMPLAINT. THE INITIAL MDR WAS INADVERTENTLY SUBMITTED AS A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THAT THE FIBER SWITCH DID NOT HANDLE THE SWITCH OVER FROM DC TO AC RESULTING IN VIDEO LOSS. HOWEVER, PER THE LEGAL MANUFACTURE, THIS ISSUE OF IMAGE LOSS DUE TO THE FIBER SWITCH IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

Description of Event or Problem

IT WAS REPORTED THE EASYSUITE INTEGRATION SYSTEM FIBER SWITCH DID NOT HANDLE THE SWITCH OVER FROM DC TO AC AND MONITORS WERE DOWN FOR ABOUT 10 MINUTES. CUSTOMER REPORTS THAT IN THE MIDDLE OF CASES THEY LOST ALL VIDEO TO THEIR TOUCH PANEL AND INFIELD AS WELL AS WALL MONITORS. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

CORRECTION IS BEING MADE TO PREVIOUSLY SUBMITTED G3 - DATE RECEIVED BY MANUFACTURER WHICH WAS NOT LATE. THE CORRECT DATE WAS 18-JUL-2024.