RESUSCITATOR BAG ADULT W/

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "OXYGEN DID NOT COME OUT OF MASK DURING PATIENT VENTILATION. HIGH FLOW OXYGEN CAME OUT OF VENT TUBING. MILD SUCTION IN MASK". THE ISSUE WAS RESOLVED BY USING A NEW MASK. NO PATIENT HARM OR INJURY.

Description of Event or Problem

IT WAS REPORTED THAT "OXYGEN DID NOT COME OUT OF MASK DURING PATIENT VENTILATION. HIGH FLOW OXYGEN CAME OUT OF VENT TUBING. MILD SUCTION IN MASK". THE ISSUE WAS RESOLVED BY USING A NEW MASK. NO PATIENT HARM OR INJURY.

Additional Manufacturer Narrative

QN# (B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "ON 10/23/2024, A NOTIFICATION SUMMARY (20049088) WAS CREATED REGARDING TELEFLEX PRODUCT 157100100. THE END USER WAS IMMEDIATELY CONTACTED, AND IT WAS DETERMINED THAT A DEVICE THAT WAS INTENDED TO BE APPLIED DURING A PATIENT PROCEDURE DID NOT PERFORM ADEQUATELY AND WAS IMMEDIATELY REPLACED WITH ANOTHER UNIT OF THE SAME MAKE AND MODEL. NO UNTOWARD OUTCOME WAS EXPERIENCED BY THE PATIENT. THE CUSTOMER WAS A VERY EXPERIENCED PRACTITIONER WHO WAS KNOWLEDGEABLE IN THE USE AND APPLICATION OF THE DEVICE. THE UNIT WAS RETAINED AND INSPECTED AND WAS DEEMED FAULTY BY THE END USER. AT THE TIME OF THE CONVERSATION, IT WAS BEING PREPARED FOR RETURN TO TELEFLEX FOR SHIPMENT TO BLS SYSTEMS LTD WHERE IT WOULD BE THOROUGHLY EXAMINED FOR MANUFACTURING AND ASSEMBLY QUALITY. AT THE DATE OF THIS WRITING, NO UNIT HAS BEEN RETURNED. UNTIL THE UNIT CAN BE INSPECTED, NO COMMENT CAN BE MADE REGARDING THE QUALITY OR PERFORMANCE OF THE DEVICE. THERE HAVE BEEN NO ISSUES OR COMPLAINTS ABOUT THIS DEVICE (ALL SIZES AND CONFIGURATIONS) FOR SEVERAL YEARS. AS A RESULT, THIS CONCERN REPRESENTS LESS THAN A SMALL FRACTION OF ONE PERCENT OF ALL RUSCH BRANDED MANUAL RESUSCITATION DEVICES. AT PRESENT, BLS SYSTEMS LTD AWAITS THE RETURN OF THE DEVICE." OTHER REMARKS: N/A; CORRECTED DATA: N/A.