BREATHING BAG

Description of Event or Problem

IT HAS BEEN VERBALLY REPORTED TO KING SYSTEMS OF A PT DEATH AT HOSP, WHERE KING SYSTEMS BREATHING CIRCUITS AND BREATHING BAGS ARE USED. THE INCIDENT, INVOLVING A PT, WAS DESCRIBED AS A TRAUMA CASE. THE PT WAS REPORTEDLY ON "HIGH VENTILATORY PRESSURES". STAFF INVOLVED WITH THE CASE INDICATED THAT THEY HEARD A "POP". THEY CHECKED THE BREATHING BAG, AND REPORTED THAT THERE WAS A "HOLE IN IT". THEY THEN TRIED USING TWO ADD'L BREATHING BAGS ON THE EQUIPMENT WITH THE SAME RESULTS. THE BREATHING BAGS ALLEGEDLY INVOLVED IN THE INCIDENT WERE NOT RETAINED. HOWEVER, A SAMPLE WITH THE SAME LOT NUMBER AND PRODUCT CODE WAS SENT FROM THE FACILITY TO KING SYSTEMS FOR TESTING. TEST RESULTS INDICATED NO DEFECTS. THE FACILITY SPOKESPERSON DID NOT ATTRIBUTE THE DEATH TO THE KING SYSTEMS BREATHING BAG(S). NO ADD'L PT OR PRODUCT INFO HAS BEEN SUPPLIED TO KING SYSTEMS.