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AIRSENSE 37207Recalls & reported problems

Resmed Pty Ltd · AIRSENSE 10 AUTOSET USA CO · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
20
Deaths reported
1
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00619498372072), received between Dec 5, 2018 and May 14, 2024 — classified as 1 death, 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fire” (13 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fire13
  • Detachment of Device or Device Component2
  • Insufficient Device Problem Information2
  • Pressure Problem2
  • Material Disintegration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • No Consequences Or Impact To Patient3
  • Burn(s)2
  • Cancer2
  • Chest Tightness/Pressure2
  • Dyspnea2
  • Injury2
  • No Patient Involvement2

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO RESMED THAT A PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY EXPIRED ON (B)(6), 2022 DUE TO ESOPHAGEAL CANCER. IT WAS REPORTED THAT THE PATIENT HAD BEEN USING AN AIRSENSE 10 AUTOSET DEVICE FOR A FEW YEARS LEADING UP TO HIS DEATH. IT WAS REPORTED THAT THE PATIENT USED A UV CLEANER TO CLEAN THEIR DEVICE. IT WAS ALLEGED THAT RESMED DEVICE MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH BASED ON THE INFORMATION OUT THERE ABOUT THE PHILIPS DEVICES. THERE WAS NO ALLEGATION OF A SPECIFIC DEVICE MALFUNCTION.

    Patient problems: Cancer

    MAUDE report 19315553 ↗
  • DeathMay 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO RESMED THAT A PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY EXPIRED ON (B)(6), 2022 DUE TO ESOPHAGEAL CANCER. IT WAS REPORTED THAT THE PATIENT HAD BEEN USING AN AIRSENSE 10 AUTOSET DEVICE FOR A FEW YEARS LEADING UP TO HIS DEATH. IT WAS REPORTED THAT THE PATIENT USED A UV CLEANER TO CLEAN THEIR DEVICE. IT WAS ALLEGED THAT RESMED DEVICE MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH BASED ON THE INFORMATION OUT THERE ABOUT THE PHILIPS DEVICES. THERE WAS NO ALLEGATION OF A SPECIFIC DEVICE MALFUNCTION.

    Patient problems: Cancer

    MAUDE report 19315551 ↗
  • MalfunctionNov 1, 2022Fire

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE ALLEGEDLY CAUGHT FIRE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15712866 ↗
  • MalfunctionNov 1, 2022Fire

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE ALLEGEDLY CAUGHT FIRE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15712864 ↗
  • MalfunctionSep 30, 2021Fire

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12551559 ↗
  • MalfunctionSep 30, 2021Fire

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12551556 ↗
  • MalfunctionMar 29, 2021Fire

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11586016 ↗
  • MalfunctionMar 29, 2021Fire

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

    Patient problems: Insufficient Information

    MAUDE report 11585981 ↗
  • MalfunctionSep 25, 2020Fire

    IT WAS REPORTED TO RESMED THAT THE POWER CORD OF AN AIRSENSE 10 DEVICE CAUGHT FIRE. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Patient problems: No Patient Involvement

    MAUDE report 10588193 ↗
  • MalfunctionSep 25, 2020Fire

    IT WAS REPORTED TO RESMED THAT THE POWER CORD OF AN AIRSENSE 10 DEVICE CAUGHT FIRE. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED. THERE WAS NO PATIENT HARM OR A SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Patient problems: No Patient Involvement

    MAUDE report 10588039 ↗
  • MalfunctionMar 10, 2020Fire; Fire

    IT WAS REPORTED THAT AN AIRSENSE 10 DEVICE CAUGHT FIRE. IT WAS REPORTED THE PATIENT¿S SON HAD A MINOR, SMALL BURN ON NECK DUE TO DEBRIS; MEDICAL ATTENTION WAS NOT SOUGHT. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT.

    Patient problems: Burn(s)

    MAUDE report 9814364 ↗
  • MalfunctionMar 10, 2020Fire; Fire

    IT WAS REPORTED THAT AN AIRSENSE 10 DEVICE CAUGHT FIRE. IT WAS REPORTED THE PATIENT¿S SON HAD A MINOR, SMALL BURN ON NECK DUE TO DEBRIS; MEDICAL ATTENTION WAS NOT SOUGHT. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT.

    Patient problems: Burn(s)

    MAUDE report 9814359 ↗
  • MalfunctionFeb 19, 2020Fire; Fire

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

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9729994 ↗
  • MalfunctionFeb 19, 2020Fire; Fire

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

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9729993 ↗
  • InjuryDec 26, 2019Pressure Problem; Pressure Problem

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET HAD A PRESSURE ISSUE AND THE PATIENT EXPERIENCED A LACK OF AIR, DEVELOPED HEART ATTACK-LIKE SYMPTOMS AND WAS TAKEN TO THE HOSPITAL. IT WAS REPORTED THE PATIENT RECOVERED.

    Patient problems: Injury

    MAUDE report 9522336 ↗
  • InjuryDec 26, 2019Pressure Problem; Pressure Problem

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET HAD A PRESSURE ISSUE AND THE PATIENT EXPERIENCED A LACK OF AIR, DEVELOPED HEART ATTACK-LIKE SYMPTOMS AND WAS TAKEN TO THE HOSPITAL. IT WAS REPORTED THE PATIENT RECOVERED.

    Patient problems: Injury

    MAUDE report 9522335 ↗
  • MalfunctionJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO RESMED THAT THE WATER CHAMBER OF A AIRSENSE 10 AUTOSET DETACHED FROM THE DEVICE CAUSING AN INCREASE IN DELIVERED PRESSURE, BURNING SENSATION OF THE PATIENT'S LUNGS, SEVERE CHEST PAIN, INABILITY TO CATCH BREATH AND HOSPITALIZATION OF THE PATIENT.

    Patient problems: Chest Tightness/Pressure; Dyspnea

    MAUDE report 8824769 ↗
  • MalfunctionJul 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO RESMED THAT THE WATER CHAMBER OF A AIRSENSE 10 AUTOSET DETACHED FROM THE DEVICE CAUSING AN INCREASE IN DELIVERED PRESSURE, BURNING SENSATION OF THE PATIENT'S LUNGS, SEVERE CHEST PAIN, INABILITY TO CATCH BREATH AND HOSPITALIZATION OF THE PATIENT.

    Patient problems: Chest Tightness/Pressure; Dyspnea

    MAUDE report 8824768 ↗
  • MalfunctionFeb 14, 2019Fire; Fire

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 DEVICE ALLEGEDLY SMOKED AND APPEARED TO START A 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 8340599 ↗
  • MalfunctionDec 5, 2018Material Disintegration; Material Disintegration

    IT WAS REPORTED TO RESMED THAT A PATIENT HAD DIFFICULTY BREATHING AND FOUND GREEN MATERIAL INSIDE THE AIRSENSE 10 AUTOSET DEVICE. THE PATIENT REPORTEDLY WENT TO THE PULMONOLOGIST WHERE IT WAS DETERMINED THAT THE PATIENT WAS BREATHING AT 60%. THE PATIENT WAS GIVEN AN INHALANT WHICH REPORTEDLY HELPED FOR A FEW DAYS.

    Patient problems: Respiratory Distress

    MAUDE report 8135944 ↗

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Sources and updates

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