AIRCURVE 37212Recalls & reported problems
Resmed Pty Ltd · AIRCURVE 10 VAUTO · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00619498372126), received between Jun 25, 2019 and Oct 31, 2025 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fire2
- Insufficient Device Problem Information1
Patient problems
- Anxiety2
- Unspecified Mental, Emotional or Behavioral Problem2
- Respiratory Distress1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Fire; Fire
IT WAS REPORTED TO RESMED THAT A PATIENT'S AIRCURVE 10 DEVICE ALLEGEDLY OVERHEATED AND CAUGHT FIRE ON (B)(6) 2024, IGNITING THE MATTRESS AND BEDDING WHILE THE PATIENT WAS ASLEEP. THE PATIENT STATED THEY HAD BEEN USING THE DEVICE FOR APPROXIMATELY THREE HOURS AND HAD FILLED THE WATER TANK PRIOR TO USE. THE FIRE WAS CONTAINED TO THE BEDROOM, WITH SMOKE DAMAGE REPORTED THROUGHOUT THE HOME. THE PATIENT REPORTED PSYCHOLOGICAL DISTRESS (PTSD AND ANXIETY) FOLLOWING THE INCIDENT.
Patient problems: Anxiety; Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 23433482 ↗MalfunctionOct 31, 2025Fire; Fire
IT WAS REPORTED TO RESMED THAT A PATIENT'S AIRCURVE 10 DEVICES ALLEGEDLY OVERHEATED AND CAUGHT FIRE ON (B)(6) 2024, IGNITING THE MATTRESS AND BEDDING WHILE THE PATIENT WAS ASLEEP. THE PATIENT STATED THEY HAD BEEN USING THE DEVICE FOR APPROXIMATELY THREE HOURS AND HAD FILLED THE WATER TANK PRIOR TO USE. THE FIRE WAS CONTAINED TO THE BEDROOM, WITH SMOKE DAMAGE REPORTED THROUGHOUT THE HOME. THE PATIENT REPORTED PSYCHOLOGICAL DISTRESS (PTSD AND ANXIETY) FOLLOWING THE INCIDENT.
Patient problems: Anxiety; Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 23433481 ↗MalfunctionJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO RESMED THAT A PATIENT WAS HOSPITALIZED WITH RESPIRATORY DISTRESS DUE TO AN UNSPECIFIED MALFUNCTION OF AN AIRCURVE 10 VAUTO.
Patient problems: Respiratory Distress
MAUDE report 8732188 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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