AIR 11 39001Recalls & reported problems
Resmed Pty Ltd · AIRSENSE 11 AUTOSET USA TRI · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00619498390014), received between Dec 1, 2021 and Nov 10, 2022 — classified as 2 injuries, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fire2
- Unintended Electrical Shock2
Patient problems
- Burn(s)2
- Chest Pain2
- Dysphagia/ Odynophagia2
- Electric Shock2
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Unspecified Heart Problem2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2022Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED TO RESMED THAT A PATIENT WAS ALLEGEDLY ELECTROCUTED BY HIS AIRSENSE 11 DEVICE DURING USE. THE PATIENT BORE BURN INJURIES. THE PATIENT SOUGHT MEDICAL ATTENTION IN AN EMERGENCY CARE UNIT. THE PATIENT IS CURRENTLY STILL EXPERIENCING PAIN IN CHEST, HEART ISSUES AND TROUBLE SWALLOWING FOLLOWING THE INCIDENT. FURTHER INFORMATION ABOUT THE PATIENT¿S MEDICAL CONDITION IS NOT AVAILABLE TO RESMED.
Patient problems: Burn(s); Chest Pain; Dysphagia/ Odynophagia; Electric Shock; Pain; Unspecified Heart Problem
MAUDE report 15769398 ↗InjuryNov 10, 2022Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED TO RESMED THAT A PATIENT WAS ALLEGEDLY ELECTROCUTED BY HIS AIRSENSE 11 DEVICE DURING USE. THE PATIENT BORE BURN INJURIES. THE PATIENT SOUGHT MEDICAL ATTENTION IN AN EMERGENCY CARE UNIT. THE PATIENT IS CURRENTLY STILL EXPERIENCING PAIN IN CHEST, HEART ISSUES AND TROUBLE SWALLOWING FOLLOWING THE INCIDENT. FURTHER INFORMATION ABOUT THE PATIENT¿S MEDICAL CONDITION IS NOT AVAILABLE TO RESMED.
Patient problems: Burn(s); Chest Pain; Dysphagia/ Odynophagia; Electric Shock; Pain; Unspecified Heart Problem
MAUDE report 15769394 ↗MalfunctionDec 1, 2021Fire; Fire
IT WAS REPORTED TO RESMED THAT AN AIRSENSE 11 POWER CORD CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912717 ↗MalfunctionDec 1, 2021Fire; Fire
IT WAS REPORTED TO RESMED THAT AN AIRSENSE 11 POWER CORD CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912711 ↗
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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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