AIRCURVE 37211Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00619498372119), received between Apr 13, 2018 and Feb 25, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fire” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Fire; Device Emits Odor; Decrease in Pressure

  IT WAS REPORTED TO RESMED THAT A PATIENT DEVELOPED A FIRST-DEGREE BURN ON THEIR RIGHT FACIAL CHEEK, ACCOMPANIED BY IRRITATION, SWELLING, DISCHARGE OF A WHITE SUBSTANCE, AND PEELING ALLEGEDLY FROM USE OF AN UNSPECIFIED MASK AND AIRCURVE 10 VAUTO DEVICE. THE PATIENT REPORTED DIFFICULTY EATING AND SLEEPING DUE TO THEIR REPORTED SYMPTOMS. THE PATIENT ALLEGED THE DEVICE WAS EMITTING A BURNING SMELL AND THE AIR DID NOT FEEL LIKE IT WAS BLOWING PROPERLY. THE PATIENT SOUGHT MEDICAL TREATMENT AT A HOSPITAL AND RECEIVED A PRESCRIPTION. THERE WAS NO REPORT OF VISIBLE FLAME OBSERVED FROM THE DEVICE OR EXTERNAL DAMAGE OF THE DEVICE. ON (B)(6) 2026, RESMED WAS INFORMED THAT THE DEVICE ALLEGEDLY CAUGHT FIRE.

  Patient problems: Skin Inflammation/ Irritation; Superficial (First Degree) Burn; Swelling/ Edema

  MAUDE report 24448889 ↗
• InjuryFeb 25, 2026Fire; Device Emits Odor; Decrease in Pressure

  IT WAS REPORTED TO RESMED THAT A PATIENT DEVELOPED A FIRST-DEGREE BURN ON THEIR RIGHT FACIAL CHEEK, ACCOMPANIED BY IRRITATION, SWELLING, DISCHARGE OF A WHITE SUBSTANCE, AND PEELING ALLEGEDLY FROM USE OF AN UNSPECIFIED MASK AND AIRCURVE 10 VAUTO DEVICE. THE PATIENT REPORTED DIFFICULTY EATING AND SLEEPING DUE TO THEIR REPORTED SYMPTOMS. THE PATIENT ALLEGED THE DEVICE WAS EMITTING A BURNING SMELL AND THE AIR DID NOT FEEL LIKE IT WAS BLOWING PROPERLY. THE PATIENT SOUGHT MEDICAL TREATMENT AT A HOSPITAL AND RECEIVED A PRESCRIPTION. THERE WAS NO REPORT OF VISIBLE FLAME OBSERVED FROM THE DEVICE OR EXTERNAL DAMAGE OF THE DEVICE. ON JANUARY 15, 2026, RESMED WAS INFORMED THAT THE DEVICE ALLEGEDLY CAUGHT FIRE.

  Patient problems: Skin Inflammation/ Irritation; Superficial (First Degree) Burn; Swelling/ Edema

  MAUDE report 24448887 ↗
• InjuryOct 19, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED TO RESMED THAT THE PRESSURE DELIVERED FROM AN AIRSENSE 10 CPAP WAS GREATER THAN 30 PSI. SERIOUS INJURY WITH REQUIRED INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12662681 ↗
• MalfunctionOct 19, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED TO RESMED THAT THE PRESSURE DELIVERED FROM AN AIRSENSE 10 CPAP WAS GREATER THAN 30 PSI. SERIOUS INJURY WITH REQUIRED INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12662680 ↗
• MalfunctionApr 13, 2018Fire; Fire

  IT WAS REPORTED TO RESMED THAT AN AIRCURVE 10 VAUTO DEVICE ALLEGEDLY CAUGHT FIRE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7429103 ↗