EASYSUITE 4K INTEGRATION SYS MODEL 1200

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. TECHNICAL ASSISTANCE CENTER (TAC) COMMUNICATION WITH THE CUSTOMER NOTED THAT THIS AN ONGOING ISSUE THAT MIGHT BE RELATED TO THE FIBER CABLING IN THE FACILITY SITE OPERATING ROOM (OR). THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

IT WAS REPORTED THAT 4 EASYSUITE SYSTEMS (MODEL ISM-1005408) ARE HAVING THE SAME VIDEO DISPLAYING PROBLEMS IN WHICH THE BOTTOM RIGHT PART OF THE IMAGE IS NOT DISPLAYING. PER THE REPORT, ONE PART OF THE IMAGE WAS NOT SHOWING UP. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT INCLUDES 4 REPORTS ADDRESSING THE REPORTED ISSUE OF THE 4 EASYSUITE SYSTEMS. REPORT WITH PATIENT IDENTIFIERS: (B)(6); MODEL ISM-1005408- SN: (B)(6); (B)(6); MODEL ISM-1005408- SN: (B)(6); (B)(6); MODEL ISM-1005408- SN: (B)(6); (B)(6); MODEL ISM-1005408- SN: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6); MODEL ISM-1005408- SN: (B)(6).