inforMED
MalfunctionCAT

N/A

Received Jun 12, 2026 · Event occurred Mar 4, 2026

Report 3004748541-2026-00112 · MDR key 25494235

Device

Generic name

Nasal Cannula (adult) High Flow With 7' (2.1 M) Supply Tube, For Flows Up To 15

Manufacturer

Salter Labs

Model number

1600HF-7-25

Catalog number

1600HF-7-25

Lot number

557367

Product problems

  • Insufficient Flow or Under Infusion

Patient

NA · Unknown

  • Low Oxygen Saturation

Narrative

Description of Event or Problem

IT WAS REPORTED THAT RESIDENT WAS WEARING HIGH FLOW NASAL PRONG TUBING WHEN THEY NOTICED THE TUBING HAD BECOME DISCONNECTED NEAR THE NASAL PRONG CONNECTION PORT.

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 12 JUNE 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.