AIRSENSE 37210Recalls & reported problems
Resmed Pty Ltd · AIRSENSE 10 AUTOSET · Class 2
- 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 00619498372102), received between Jul 28, 2021 and Jul 28, 2021 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Superficial (First Degree) Burn2
- Erythema1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO RESMED THAT CLIMATELINE AIR TUBING USED WITH AN AIRSENSE 10 DEVICE ALLEGEDLY BURNED THE PATIENT'S ARMS. IT WAS REPORTED THAT THE PATIENT WAS ASLEEP IN HER BED, AWOKE AND NOTICED BURNS TO HER RIGHT AND LEFT ARM NEAR THE ELBOWS. IT WAS REPORTED THE PATIENT VISITED URGENT CARE AND WAS ADVISED TO APPLY OVER THE COUNTER OINTMENT TO THE SKIN. THE PATIENT REPORTEDLY VISITED A PHYSICIAN ASSISTANT AND WAS ADVISED THE ENTIRE HEALING PROCESS MAY TAKE A FEW MONTHS, HYPERPIGMENTATION MAY TAKE SEVERAL MONTHS TO YEARS TO RESOLVE AND MAY NOT RESOLVE COMPLETELY. THE PATIENT IS CURRENTLY RECOVERING AND HAS BANDAGES ON HER ARMS.
Patient problems: Erythema; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn
MAUDE report 12243512 ↗InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO RESMED THAT CLIMATELINE AIR TUBING USED WITH AN AIRSENSE 10 DEVICE ALLEGEDLY BURNED THE PATIENT'S ARMS. IT WAS REPORTED THAT THE PATIENT WAS ASLEEP IN HER BED, AWOKE AND NOTICED BURNS TO HER RIGHT AND LEFT ARM NEAR THE ELBOWS. IT WAS REPORTED THE PATIENT VISITED URGENT CARE AND WAS ADVISED TO APPLY OVER THE COUNTER OINTMENT TO THE SKIN. THE PATIENT REPORTEDLY VISITED A PHYSICIAN ASSISTANT AND WAS ADVISED THE ENTIRE HEALING PROCESS MAY TAKE A FEW MONTHS, HYPERPIGMENTATION MAY TAKE SEVERAL MONTHS TO YEARS TO RESOLVE AND MAY NOT RESOLVE COMPLETELY. THE PATIENT IS CURRENTLY RECOVERING AND HAS BANDAGES ON HER ARMS.
Patient problems: Superficial (First Degree) Burn
MAUDE report 12243504 ↗
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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/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.