MEDLINE

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31 OCT 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATI ON IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "PRESSURE IS LOST WHEN TORQUE IS APPLIED" REGARDING PART CPRM4426 WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THERE WAS NO EQUIPMENT IN PLACE TO ENSURE OR DETECT VACUUM-RELATED FAILURES OF AIRFLOW IN THE BAG OR VALVE AT THE TIME OF MANUFACTURE. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS. 1.PATIENT/CAREGIVER PERFORMED RISK ASSESSMENT WITH RMA-20020 REVISION 6; THE MOST CLOSELY ASSOCIATED RISK IS ID R48 (P1=1, P2=1) WITH A PROBABILITY OF HARM OCCURRING P=1 AND SEVERITY S=3 WHICH IS LOW RISK. THE CALCULATED P1 BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS IS 2/5 - REMOTE. THEREFORE, THE PROBABILITY OF HARM OCCURRING (P) REMAINS THE SAME AS THE RMA AND IS DETERMINED TO BE LOW RISK PER REF-20001-C1 REV2. 2. REGULATORY/ COMPLIANCE REVIEWED REF-20001-C1 REV2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK. 3. BRAND RECOGNITION AND CUSTOMER IMPACT REVIEWED REF-20001-C1 REV2, AND THERE IS MEDIUM BRAND RECOGNITION/CUSTOMER IMPACT.

Description of Event or Problem

IT WAS REPORTED THAT THE ISSUE PREVENTS ADEQUATE DELIVERY OF POSITIVE PRESSURE WHEN THE BAG IS NOT HELD PERFECTLY STRAIGHT, AS PRESSURE IS LOST WHEN TORQUE IS APPLIED AT THE JUNCTION TO THE ADAPTER. .THE RESUSCITATION BAG WAS BEING USED TO VENTILATE AND THE PATIENT DESATURATED AND FAILED TO PROGRESS; THE RESUSCITATION BAG WAS REPLACED AND THE PATIENT'S VENTILATION/OXYGEN SATURATION IMPROVED. THERE WAS NO REPORTED INJURY.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31 OCT 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATI ON IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

Description of Event or Problem

IT WAS REORTED THAT THE ISSUE PREVENTS ADEQUATE DELIVERY OF POSITIVE PRESSURE WHEN THE BAG IS NOT HELD PERFECTLY STRAIGHT, AS PRESSURE IS LOST WHEN TORQUE IS APPLIED AT THE JUNCTION TO THE ADAPTER. THE RESUSCITATION BAG WAS BEING USED TO VENTILATE AND THE PATIENT DESATURATED AND FAILED TO PROGRESS; THE RESUSCITATION BAG WAS REPLACED AND THE PATIENT'S VENTILATION/OXYGEN SATURATION IMPROVED. THERE WAS NO REPORTED INJURY.