AIRLIFE

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 18 JULY 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 "2 CASES OF HOSPITAL ACQUIRED PRESSURE INJURY FROM THE NASAL CANNULAS" REGARDING PART FM2699 WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. 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 NO 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. RISK ASSESSMENT: THE ULTIMATE RISK IS LOW, AS THAT IS THE HIGHEST RISK OF THE PATIENT/CAREGIVER AND REGULATORY/COMPLIANCE CONSIDERATIONS: 1.PATIENT/CAREGIVER (NOTE: TO BE USED WITH UPDATED AIRLIFE RMA FILES ON THE 5-POINT SEVERITY SCALE) PERFORMED RISK ASSESSMENT WITH RMA-20017AF, REVISION1; THE MOST CLOSELY ASSOCIATED RISK IS ID R115 (P1=1, P2=1) WITH A PROBABILITY OF HARM OCCURRING P=1 AND SEVERITY S=2 WHICH IS LOW RISK. THE CALCULATED P1 BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS IS 1. 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. REGULATORY/ COMPLIANCE REVIEWED REF-20001-C1 REV2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT(S) ACQUIRED PRESSURE INJURY FROM THE NASAL CANNULAS. THERE WAS NO REPORT OF MEDICAL INTERVENTION. SINCE THERE WERE TWO REPORTS OF INJURY A SECONDARY MDR WILL BE SUBMITTED WITH THIS ONE TWO DOCUMENT BOTH INJURIES. THE SECOND MDR IS 1314417-2025-00049.

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 18 JULY 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 THE PATIENT(S) ACQUIRED PRESSURE INJURY FROM THE NASAL CANNULAS. THERE WAS NO REPORT OF MEDICAL INTERVENTION. SINCE THERE WERE TWO REPORTS OF INJURY A SECONDARY MDR WILL BE SUBMITTED WITH TWO DOCUMENTS BOTH INJURIES. THE SECOND MDR IS 1314417-2025-00049.