AIRSENSE 37203Recalls & reported problems
Resmed Pty Ltd · AIRSENSE 10 CPAP · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00619498372034), received between Aug 4, 2021 and Aug 4, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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
- Excess Flow or Over-Infusion2
- Improper or Incorrect Procedure or Method2
Patient problems
- Aspiration/Inhalation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2021Excess Flow or Over-Infusion; Improper or Incorrect Procedure or Method
IT WAS REPORTED TO RESMED THAT A PATIENT MISTAKENLY TURNED THE HUMIDITY OF HIS AIRSENSE 10 DEVICE UP TO 8 WHICH CAUSED EXCESS WATER MOISTURE WITHIN THE PATIENT¿S NASAL MASK THAT THE PATIENT ASPIRATED. IT WAS REPORTED THE PATIENT VISITED AN EMERGENCY DEPARTMENT 2 DAYS LATER DUE TO THIS INCIDENT AND IS CURRENTLY RECOVERING.
Patient problems: Aspiration/Inhalation
MAUDE report 12278416 ↗InjuryAug 4, 2021Excess Flow or Over-Infusion; Improper or Incorrect Procedure or Method
IT WAS REPORTED TO RESMED THAT A PATIENT MISTAKENLY TURNED THE HUMIDITY OF HIS AIRSENSE 10 DEVICE UP TO 8 WHICH CAUSED EXCESS WATER MOISTURE WITHIN THE PATIENT¿S NASAL MASK THAT THE PATIENT ASPIRATED. IT WAS REPORTED THE PATIENT VISITED AN EMERGENCY DEPARTMENT 2 DAYS LATER DUE TO THIS INCIDENT AND IS CURRENTLY RECOVERING.
Patient problems: Aspiration/Inhalation
MAUDE report 12278404 ↗
Other Ventilator, Non-Continuous (Respirator) devices
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- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- 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
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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