AIRSENSE 37208Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00619498372089), received between Oct 26, 2017 and Sep 23, 2026 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fire” (15 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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fire

  It was reported to Resmed that a patient¿s AirSense 10 device allegedly caught fire while the patient was away at work. It was reported that the smoke alarm in the patient's home was activated and that the fire department were called. According to the patient, the fire allegedly originated from the device and spread to nearby curtains and a dresser, resulting in property damage. No personal injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863104 ↗
• MalfunctionSep 23, 2026Fire

  It was reported to Resmed that a patient¿s AirSense 10 device allegedly caught fire while the patient was away at work. It was reported that the smoke alarm in the patient's home was activated and that the fire department were called. According to the patient, the fire allegedly originated from the device and spread to nearby curtains and a dresser, resulting in property damage. No personal injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863078 ↗
• MalfunctionNov 23, 2021Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE WAS INVOLVED IN A HOUSE FIRE. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 12862879 ↗
• MalfunctionNov 23, 2021Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE WAS INVOLVED IN A HOUSE FIRE. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862876 ↗
• InjuryJun 10, 2020Device Dislodged or Dislocated

  IT WAS REPORTED TO RESMED THAT A PIECE OF AN AIRSENSE 10 AND MASK WAS ALLEGEDLY DISLODGED, AND WENT UP THE PATIENT'S NOSE BY THE PRESSURE OF THE DEVICE CAUSING FACIAL PAIN, LEAVING A RED MARK ON SIDE OF FACE, AND BLEEDING FROM THE NOSE & MOUTH. THE PATIENT HAS ALLEGED TO HAVE SOUGHT MEDICAL ATTENTION AT AN URGENT CARE CLINIC AND WAS REFERRED TO AN EAR NOSE & THROAT SPECIALIST. RESMED HAS NOT BEEN PROVIDED ANY MEDICAL STATEMENTS FROM THE PATIENT OR A MEDICAL PROFESSIONAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10141477 ↗
• InjuryJun 10, 2020Device Dislodged or Dislocated

  IT WAS REPORTED TO RESMED THAT A PIECE OF AN AIRSENSE 10 AND MASK WAS ALLEGEDLY DISLODGED, AND WENT UP THE PATIENT'S NOSE BY THE PRESSURE OF THE DEVICE CAUSING FACIAL PAIN, LEAVING A RED MARK ON SIDE OF FACE, AND BLEEDING FROM THE NOSE & MOUTH. THE PATIENT HAS ALLEGED TO HAVE SOUGHT MEDICAL ATTENTION AT AN URGENT CARE CLINIC AND WAS REFERRED TO AN EAR NOSE & THROAT SPECIALIST. RESMED HAS NOT BEEN PROVIDED ANY MEDICAL STATEMENTS FROM THE PATIENT OR A MEDICAL PROFESSIONAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10141475 ↗
• MalfunctionFeb 19, 2020Fire; Fire

  IT WAS ALLEGEDLY REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729997 ↗
• MalfunctionFeb 19, 2020Fire; Fire

  IT WAS ALLEGEDLY REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729992 ↗
• MalfunctionFeb 5, 2020Fire; Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673958 ↗
• MalfunctionFeb 5, 2020Fire; Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673950 ↗
• MalfunctionOct 23, 2019Fire; Fire

  IT WAS ALLEGEDLY REPORTED TO RESMED THAT THE CORD OF AN AIRSENSE 10 AUTOSET DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227552 ↗
• MalfunctionOct 23, 2019Fire; Fire

  IT WAS ALLEGEDLY REPORTED TO RESMED THAT THE CORD OF AN AIRSENSE 10 AUTOSET DEVICE CAUGHT FIRE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227542 ↗
• MalfunctionJul 31, 2019Fire; Fire

  IT WAS ALLEGEDLY REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET CAUGHT FIRE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849051 ↗
• MalfunctionJul 31, 2019Fire; Fire

  IT WAS ALLEGEDLY REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET CAUGHT FIRE. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849050 ↗
• InjuryJul 30, 2019Fire; Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET CAUGHT FIRE WHILE IN USE ON A PATIENT. IT WAS REPORTED THE PATIENT SOUGHT MEDICAL EVALUATION AT THE HOSPITAL FOR POSSIBLE SMOKE INHALATION (NO BURNS REPORTED) AND HAS RECOVERED.

  Patient problems: Injury

  MAUDE report 8844120 ↗
• InjuryJul 30, 2019Fire; Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET CAUGHT FIRE WHILE IN USE ON A PATIENT. IT WAS REPORTED THE PATIENT SOUGHT MEDICAL EVALUATION AT THE HOSPITAL FOR POSSIBLE SMOKE INHALATION (NO BURNS REPORTED) AND HAS RECOVERED.

  Patient problems: Injury

  MAUDE report 8844118 ↗
• InjuryOct 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO RESMED THAT A PATIENT WAS FOUND WITH BLOODY EMESIS AND DISTENDED ABDOMEN WHILE USING AN AIRSENSE 10 AUTOSET DEVICE WITH QUATTRO FX FFM LARGE. PATIENT WAS TAKEN TO THE HOSPITAL AND UNDERWENT EXPLORATORY ABDOMINAL SURGERY WHICH REPORTEDLY FOUND COMPRESSED AIR IN THE STOMACH AND BOWELS. SURGEON DETERMINED THE PATIENT HAD ASPIRATION PNEUMONIA. PATIENT HAS DISCONTINUED CPAP THERAPY. RESMED HAS NOT EXAMINED DEVICE. PATIENT'S WIFE REPORTED THE DEVICE WENT ROGUE.

  Patient problems: Aspiration/Inhalation; Pneumonia

  MAUDE report 7956435 ↗
• MalfunctionOct 26, 2017Fire; Fire

  IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET USA TRI VPAP WAS ALLEGEDLY INVOLVED IN A FIRE. THE DEVICE WAS NOT IS USE AND NOT TURNED ON AT THE TIME OF THE EVENT, THEREFORE, THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980582 ↗