AIRLIFE

Description of Event or Problem

IT WAS REPORTED THAT CANNULAS POPPING OFF WATER BOTTLES. WE HAVE WALKED INTO ROOMS, AND THE CANNULA IS COMPLETELY OFF AND THE BABY IS NOT RECEIVING OXYGEN.

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 23 JAN 2026 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 CANNULAS POPPING OFF WATER BOTTLES. WE HAVE WALKED INTO ROOMS, AND THE CANNULA IS COMPLETELY OFF AND THE BABY IS NOT RECEIVING OXYGEN.

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 23 JAN 2026 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 (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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. RISK ASSESSMENT: THE ULTIMATE RISK IS MEDIUM, AS THAT IS THE HIGHEST RISK OF THE PATIENT/CAREGIVER AND REGULATORY/COMPLIANCE CONSIDERATIONS: 1.PATIENT/CAREGIVER PERFORMED RISK ASSESSMENT WITH RMA-20017AF, REVISION 1; THE MOST CLOSELY ASSOCIATED RISK IS ID R23 (P1=1, P2=1) WITH A PROBABILITY OF HARM OCCURRING P=1 AND SEVERITY S=4 (CRITICAL) WHICH IS MEDIUM RISK. THE CALCULATED P1 BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS IS REMOTE (2). THEREFORE, THE PROBABILITY OF HARM OCCURRING (P) IS THE SAME AS THE RMA AND IS DETERMINED TO BE MEDIUM 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. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES (B)(6) 2023 THROUGH (B)(6) 2025, FOR PART NUMBER SFT2601 AND FAILURE MODE "A1202 - DECOUPLING". THERE WAS 2 OTHER COMPLAINTS REPORTED FOR THE SAME ISSUE AND PART NUMBER UNDER (B)(4) DURING THE SAME TIMEFRAME. SALES = (B)(4). CALCULATED OCCURRENCE (P1) = (B)(4). OCCURRENCE RANKING = REMOTE (2). AFFECTED DEVICE INVESTIGATION: THERE ARE NO PHOTOS, VIDEOS, OR SAMPLES AVAILABLE SO THE COMPLAINT COULD NOT BE CONFIRMED. NO RM FOUND IN SALESPAD. DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE DEVICE HISTORY RECORD (DHR) REVIEW THERE WERE NO ABNORMAL PROCESSING ISSUES NOTED. ALL PRODUCTS/PACKAGING WERE PRODUCED PER THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND INSPECTIONS.