N/A 1601-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411100383), received between Oct 18, 2023 and Jan 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Break; Connection Problem; Break; Connection Problem

  1 SECTION FROM NASAL PRONG CONNECTION POINT BROKEN/DISCONNECTED, REPLACED PRONGS WITH DESIRED EFFECT NOTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED OXYGEN DESATURATION, WHICH WAS RESOLVED BY REPLACING THE NASAL CANNULA & CAUSED A DELAY IN CARE. ADDITIONALLY, IF THE INCIDENT HAD NOT BEEN ADDRESSED, THE PATIENT COULD HAVE BEEN AT RISK OF SERIOUS HARM OR INJURY DUE TO THE DECREASING OXYGEN LEVELS CAUSED BY A LEAK IN THE OXYGEN TUBING CONNECTIONS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21074744 ↗
• MalfunctionFeb 23, 2024Connection Problem; Connection Problem

  IT WAS OBSERVED THAT THE LOW FLOW NASAL CANNULA BROKE WHILE BEING TAKEN OFF THE PATIENT. THE TUBING SEEMED TO HAVE COME LOOSE FROM THE PART OF THE CANNULA THAT RESTS IN THE PATIENT'S NOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773722 ↗
• MalfunctionOct 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  OXYGEN NASAL PRONG LEADS BROKE FROM MAIN PORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17962051 ↗