WARMER DRAPE WITH SKIRT

Additional Manufacturer Narrative

A SAMPLE WAS RECEIVED FOR EVALUATION. THE DRAPE WAS DECONTAMINATED THEN PLACED OVER A WARMER. WATER WAS POURED INTO THE WARMER AND LEFT OVERNIGHT. THERE WAS WATER IN THE BASIN UNDER THE DRAPE. A SMALL BURN MARK WITH A VERY SMALL, UNNOTICEABLE HOLE WAS FOUND. THE DHR WAS REVIEWED AND IT WAS CONFIRMED THAT LOT D172213 HAD (B)(4) CASES THAT WERE MANUFACTURED FROM 08/10/2017 TO 08/13/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

OPERATING ROOM (OR) TECHS SAID THERE WAS FLUID UNDER THE DRAPE FOLLOWING A SURGERY IT WAS USED ON. THEY SAID THAT THE FLUID LEVELS IN THE WARMER WERE KEPT AT APPROPRIATE LEVELS THROUGHOUT THE CASE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.