Astral 100Recalls & reported problems
Resmed Pty Ltd · Portable ventilator · Class 2
Quick summary
This ResMed Astral 100 portable home ventilator provides breathing support. Most of the 864 reports describe battery and charging problems, calibration problems and screens that show wrong messages or stop responding. The reports include 9 deaths and 6 injuries; some describe a patient who became unresponsive during ventilator support, with caregivers reportedly hearing no alarm. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 865
- Deaths reported
- 9
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 865 adverse event reports that list this exact device (DI 00619498270019), received between Mar 3, 2016 and Aug 28, 2026 — classified as 9 deaths, 7 injuries, 849 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (317 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
Most reported problems
Device problems
- Protective Measures Problem317
- Battery Problem169
- Failure to Calibrate99
- Device Displays Incorrect Message91
- Failure to Charge79
- Display or Visual Feedback Problem58
- Inadequate User Interface44
- Failure of Device to Self-Test39
Patient problems
- No Clinical Signs, Symptoms or Conditions391
- No Consequences Or Impact To Patient366
- Insufficient Information50
- No Patient Involvement49
- Death5
- Loss of consciousness5
- Low Oxygen Saturation3
- Choking2
Recent adverse event reports
The 25 most recent of 865 reports, in the reporter's own words as published by the FDA.
DeathAug 28, 2026No Audible Alarm
It was reported to Resmed that a patient expired while using an Astral 100 device. It was reported that the patient became unresponsive while receiving ventilatory support from the device and no alarms were reportedly heard by the caregivers at the time of the event. The mother called for assistance, and family members initiated CPR prior to the arrival of emergency responders. Upon arrival of emergency responders, they assumed resuscitation efforts, and transported the patient by ambulance to a hospital, after which the patient was transferred to another hospital for a higher level of care. The patient was pronounced deceased at the hospital.
Patient problems: Loss of consciousness
MAUDE report 50505593 ↗DeathAug 28, 2026No Audible Alarm
Patient problems: Loss of consciousness
MAUDE report 50505590 ↗InjuryAug 19, 2026Use of Device Problem
It was reported to Resmed that an Astral device displayed a 'low pressure' alarm while in use. Learn Circuit was performed and the device displayed 'without SpO2 monitoring'. The patient was placed on a different device. The patient's SpO2 was 88% and manual ventilation was provided.
Patient problems: Low Oxygen Saturation
MAUDE report 50332128 ↗MalfunctionJun 10, 2026Failure to Power Up
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462712 ↗MalfunctionJun 10, 2026Failure to Power Up
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25462695 ↗MalfunctionJun 8, 2026Battery Problem
DURING RESMED EVALUATION, AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM AND FAILED TO CHARGE ITS INTERNAL BATTERY. 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 25423216 ↗MalfunctionJun 5, 2026Battery Problem
DURING RESMED EVALUATION, AN ASTRAL DEVICE DISPLAYED A BATTERY INOPERABLE ALARM AND FAILED TO CHARGE ITS INTERNAL BATTERY. 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 25417974 ↗MalfunctionJun 5, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 140) RELATED TO ALARM PRIORITY. THERE WAS NO HARM OR INJURY REPORTED AS A RESULT OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25403504 ↗MalfunctionJun 5, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF 140) RELATED TO ALARM PRIORITY. THERE WAS NO HARM OR INJURY REPORTED AS A RESULT OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25403503 ↗MalfunctionJun 1, 2026Power Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A TOTAL POWER FAILURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351668 ↗MalfunctionJun 1, 2026Power Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD A TOTAL POWER FAILURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351640 ↗MalfunctionMay 14, 2026Power Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE ALARMED WHEN PLUGGED IN AND DID NOT POWER ON. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178451 ↗MalfunctionMay 14, 2026Power Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE ALARMED WHEN PLUGGED IN AND DID NOT POWER ON. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178450 ↗MalfunctionMay 7, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO THE SUPER CAPACITOR. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25115795 ↗MalfunctionMay 7, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO THE SUPER CAPACITOR. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25115794 ↗MalfunctionApr 30, 2026Inadequate User Interface
DURING RESMED EVALUATION, AN ASTRAL DEVICE HAD AN INOPERABLE TOUCHSCREEN. THERE WAS NO REPORTED HARM OR INJURY AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050759 ↗MalfunctionApr 30, 2026Inadequate User Interface
DURING RESMED EVALUATION, AN ASTRAL DEVICE HAD AN INOPERABLE TOUCHSCREEN. THERE WAS NO REPORTED HARM OR INJURY AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050754 ↗MalfunctionApr 22, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF82) RELATED TO THE ALARM SYSTEM. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957898 ↗MalfunctionApr 22, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF82) RELATED TO THE ALARM SYSTEM. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957849 ↗MalfunctionApr 14, 2026Battery Problem; Protective Measures Problem
DURING RESMED EVALUATION, AN ASTRAL DEVICE DISPLAYED A BATTERY ERROR MESSAGE. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877352 ↗MalfunctionApr 14, 2026Battery Problem; Protective Measures Problem
DURING RESMED EVALUATION, AN ASTRAL DEVICE DISPLAYED A BATTERY ERROR MESSAGE. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877350 ↗MalfunctionApr 9, 2026Battery Problem; Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED BATTERY ERROR MESSAGES. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836181 ↗MalfunctionApr 9, 2026Battery Problem; Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED BATTERY ERROR MESSAGES. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836177 ↗MalfunctionApr 9, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF147) RELATED TO THE MAIN BLOWER. THERE WAS NO HARM OR INJURY REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835209 ↗MalfunctionApr 9, 2026Protective Measures Problem
IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF147) RELATED TO THE MAIN BLOWER. THERE WAS NO HARM OR INJURY REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835208 ↗
Other Continuous, Ventilator, Home Use devices
- Astral 150Resmed Pty Ltd · Continuous, Ventilator, Home Use1 recall17 deaths2,361 reports
- Trilogy EV300, USA DS2200X11BRespironics, Inc. · Continuous, ventilator, home use5 recalls2,071 reports
- Trilogy 00Respironics, Inc. · CONTINUOUS, VENTILATOR, HOME USE15 deaths2,059 reports
- Trilogy Evo, Japan JP2110X16BRespironics, Inc. · Continuous, ventilator, home use5 recalls27 deaths1,112 reports
- Trilogy Trilogy Evo Ventilator, IntlRespironics, Inc. · CONTINUOUS, VENTILATOR, HOME USE4 recalls3 deaths648 reports
- Life2000 MS-01-0118Welch Allyn, Inc. · Continuous, ventilator, home use10 recalls2 reports
- Trilogy Evo GB2110X15BRespironics, Inc. · Continuous, ventilator, home use5 recalls1 death141 reports
- Trilogy Evo FX2100X15BRespironics, Inc. · Continuous, ventilator, home use5 recalls1 death128 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.