AIRSENSE 37205Recalls & reported problems
Resmed Pty Ltd · AIRSENSE 10 ELITE · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00619498372058), received between Dec 28, 2020 and Dec 28, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fire” (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
Device problems
- Fire2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2020Fire
IT WAS ALLEGEDLY REPORTED TO RESMED THAT AN AIRSENSE 10 ELITE DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11078008 ↗MalfunctionDec 28, 2020Fire
IT WAS ALLEGEDLY REPORTED TO RESMED THAT AN AIRSENSE 10 ELITE DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11078001 ↗
Other Ventilator, Non-Continuous (Respirator) devices
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- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
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- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.