D
Patient 1
ON (B)(6) 2020 AT 3:30PM AN OPERATING ROOM NURSE NOTED A BURNING SMELL COMING FROM ONE OF THE OPERATING ROOMS. THE NURSE OPENED THE DOOR TO THE ROOM AND NOTED WHITE SMOKE. SHE SUMMONED OTHER STAFF WHO NOTED THE SMOKE WAS COMING FROM THE OPERATING ROOM CMAX TABLE. THE OPERATING ROOM TABLE WAS UNPLUGGED AND ENGINEERING AND BIOMEDICAL WERE NOTIFIED. THE FIRE DEPARTMENT WAS ALSO NOTIFIED AND ARRIVED ON THE SCENE. THE FIRE DEPARTMENT ASSISTED WITH SMOKE EVACUATION AND SECURED THE AREA. THERE WAS NO PATIENT IN THE ROOM AT THE TIME AS CASES WERE DONE FOR THE DAY. ALL SIMILAR TABLES WERE REMOVED FROM SERVICE. AND EVALUATED BY THE VENDOR. NO ISSUES WERE IDENTIFIED. A SILICON SEALANT WAS APPLIED TO THE TABLES AS IT WAS THOUGH THAT FLUID MAY HAVE SEEPED INTO THE PEDESTAL BASE WHICH IS NOT IMPERVIOUS TO FLUID. THERE WAS A HYSTEROSCOPY CASE DONE IN THE ROOM WITHIN 30 MINUTES OF THE SMOKE. THERE WAS ABOUT 300CC OF FLUID ON THE OPERATING ROOM FLOOR WHICH IS TYPICAL FOR THIS TYPE OF CASE. THE ROOM HAD BEEN CLEANED AND THE FLOOR WAS DRY AT THE TIME OF THIS EVENT. FDA SAFETY REPORT ID # (B)(4).