ACUCARE HFNC 23004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00619498230044), received between May 13, 2021 and May 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2021Material Split, Cut or Torn

  IT WAS REPORTED TO RESMED THAT A HOSPITAL PATIENT HAD AN OXYGEN DESATURATION DUE TO A TEAR IN THE CORRUGATED TUBING OF AN ACUCARE MASK. THE MASK WAS DELIVERING OXYGEN TO THE PATIENT AT THE TIME THEIR DESATURATION WAS OBSERVED. THE TEAR IN THE MASK TUBING DID NOT RESULT IN PERMANENT HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11816562 ↗
• MalfunctionMay 13, 2021Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED TO RESMED THAT A HOSPITAL PATIENT HAD AN OXYGEN DESATURATION DUE TO A TEAR IN THE CORRUGATED TUBING OF AN ACUCARE MASK. THE MASK WAS DELIVERING OXYGEN TO THE PATIENT AT THE TIME THEIR DESATURATION WAS OBSERVED. THE TEAR IN THE MASK TUBING DID NOT RESULT IN PERMANENT HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11816555 ↗