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 19 NOV 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: THE OXYGEN CONNECTOR THAT "TEE'D" INTO THE OXYGEN TO THE PATIENT'S CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) SNAPPED OFF. THERE WAS NO APPARENT HARM TO THE PATIENT.

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 19 NOV 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 "LEAK" REGARDING PART 004081 WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES REQUIRE ESCALATION TO THE CAPA REVIEW BOARD WITH ECL-204. THERE HAVE BEEN 3 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. THE DEVICE HISTORY RECORD FOR THE PART NUMBER 004081 WITH LOT NUMBER 0004326904 AND UDI CODE (B)(4) WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THE REPORTED DEFECT, THE COMPLETE LOT WAS MANUFACTURED, INSPECTED AND RELEASED ON 07JUL2025 PER OUR INTERNAL PROCEDURES AND NO ISSUES WERE FOUND. PERFORMED RISK ASSESSMENT WITH RMF-RC-202 REV 01; RISK ASSOCIATED WITH HAVING MISASSEMBLED COMPONENT IS RISK ID NHC-SHA-02 WITH A P1= UNANTICIPATED, P2= SOMEWHAT LIKELY, P= NEGLIGIBLE AND SEVERITY= MINOR WHICH IS LOW RISK (06). THE CALCULATED P1 IS BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS (1 COMPLAINT(S) / (B)(4) UNITS = (B)(4)) AND IS UNANTICIPATED. THEREFORE, P= NEGLIGIBLE AND THE OVERALL RISK IS DETERMINED TO REMAIN AT LOW RISK (06). AS A RESULT, CAPA CONDITIONAL DOES NOT APPLY, DUE TO THE OVERALL RISK BEING LOW. THEREFORE, THIS ISSUE DOES NOT MEET THE CARB ESCALATION CRITERIA.

Description of Event or Problem

IT WAS REPORTED: THE OXYGEN CONNECTOR THAT "TEE'D" INTO THE OXYGEN TO THE PATIENT'S CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) SNAPPED OFF. THERE WAS NO APPARENT HARM TO THE PATIENT.