QUATTRO AIR/ AIRFIT F 10 62738Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00619498627387), received between Mar 12, 2018 and Mar 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2018Device Emits Odor; Material Integrity Problem

  ORDERED 2 RESMED MEDIUM SIZE REPLACEMENT CUSHIONS ((B)(4)) FOR MY RESMED QUATTRO AIR MASK FROM AMAZON SELLER (B)(4), I OPENED THE FIRST SEALED PLASTIC CONTAINER AND NOTICED A STRONG CHEMICAL SMELL. THERE HAVE BEEN NO SUCH SMELLS IN MY 7 YEARS OF USING RESMED CPAP MACHINES, CUSHIONS OR MASKS. I WASHED THE CUSHION (WHICH INCLUDES THE PLASTIC MASK) IN WARM WATER AND SOAP. IT MADE NO DIFFERENCE. I NOTICED THAT THE PACKAGES OF ALL 5 MASKS SAY "MADE IN (B)(6)". I AM CONCERNED THAT THESE ARE EITHER DEFECTIVE OR COUNTERFEIT. I OPENED ANOTHER CUSHION THAT I ORDERED FROM ANOTHER SELLER ON AMAZON. I WAS PERFECTLY FINE. NO SMELL AT ALL. THE PACKAGE SAID IT WAS MADE IN (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7334166 ↗