O2 CANNULA

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 25 MARCH 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 HIGH FLOW NASAL PRONGS (GREEN) WERE INCOMPATIBLE WITH THE NEW O2 CORD. - CHC PCS260223J58EDW LEVEL OF EFFECT: MINIMAL TEMPORARY HARM. "PATIENT COMPLAINED TO WRITER THAT HE FELT TIRED AND STARTED TO HAVE HEADACHE. PATIENT HAS POOR PERIPHERAL CIRCULATION AND SPO2 READING WAS HARD TO OBTAIN BUT EVENTUALLY, IT WAS 78%. I WAS WANDERING WHY SUDDEN DROP IN SATURATION WHEN HE WAS DOING SO WELL IN LAST FEW DAYS. I FOLLOWED THE NP LINE AND REALIZED THAT NASAL PRONGS WERE NOT CONNECTED TO O2 AND HE WAS SITTING PRACTICALLY ON RA."