VITAL SIGNS

Description of Event or Problem

IT WAS REPORTED THAT THERE HAVE BEEN A FEW INSTANCES WHERE THE PATIENT SHOWED HIGH PEEP WITH LOW TIDAL VOLUME, MAKING IT DIFFICULT FOR PRACTITIONERS TO PROPERLY VENTILATE THE PATIENT. IN SOME CASES, THEY REMOVED THE CIRCUIT AND USED AN AMBU BAG, SUCCESSFULLY VENTILATING THE PATIENT. THE HME OCCLUDED DURING USE AND DID NOT ALLOW ANY AIR TO PASS THROUGH IT. THE HME BECAME A BRICK WALL AT THE FILTER. WHILE THERE WAS NO REPORTED INJURY TO THE PATIENT IF IT WERE TO REOCCUR, THERE IS A POSSIBILITY OF SERIOUS HARM OR INJURY TO THE PATIENT AND A DELAY IN THERAPY.

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 29 AUG 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 INFORMATION 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 REPORTED THAT THERE HAVE BEEN A FEW INSTANCES WHERE THE PATIENT SHOWED HIGH PEEP WITH LOW TIDAL VOLUME, MAKING IT DIFFICULT FOR PRACTITIONERS TO PROPERLY VENTILATE THE PATIENT. IN SOME CASES, THEY REMOVED THE CIRCUIT AND USED AN AMBU BAG, SUCCESSFULLY VENTILATING THE PATIENT. THE HME OCCLUDED DURING USE AND DID NOT ALLOW ANY AIR TO PASS THROUGH IT. THE HME BECAME A BRICK WALL AT THE FILTER. WHILE THERE WAS NO REPORTED INJURY TO THE PATIENT IF IT WERE TO REOCCUR THERE IS A POSSIBILITY OF SERIOUS HARM OR INJURY TO THE PATIENT AND A DELAY IN THERAPY.

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 29 AUG 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 INFORMATION 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 "OCCLUSION" REGARDING PART AMY520X4F WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED AS MATERIAL. 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.