DreamStation DreamStation Auto CPAP, NDRecalls & reported problems
Respironics, Inc. · DreamStation Auto CPAP, ND · Class 2
All models of Philips DreamStation (190)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Respironics DreamStation Auto CPAP machine, a non-continuous ventilator used for sleep apnea. Most of the 61 reports describe the sound-dampening foam inside degrading, and patients mention headaches, breathing trouble, sore throat and sinus problems afterward. There are no deaths, 34 reports of injuries and 27 of malfunctions. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00606959027206), received between Oct 22, 2020 and Nov 4, 2024 — classified as 34 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Degraded” (60 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded60
- Contamination3
- Material Protrusion/Extrusion1
- Melted1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Headache12
- Dyspnea10
- Cancer8
- Asthma7
- Unspecified Respiratory Problem4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Cough3
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2024Degraded; Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING HEADACHE, ASTHMA. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Asthma; Headache
MAUDE report 20599680 ↗InjuryNov 2, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO EXPERIENCE A SEVERE INFECTION, A COLD, INFLAMMATION OF THE EYES AND SINUSITIS. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF ANTIBIOTICS. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Inflammation; Respiratory Tract Infection
MAUDE report 12741326 ↗MalfunctionOct 14, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP HEADACHES. THE PATIENT WAS HOSPITALIZED IN RESPONSE TO THE REPORTED EVENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Headache
MAUDE report 12633497 ↗InjuryOct 9, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO DEVELOP TWO NODULES IN ONE LUNG ALONG WITH EXPERIENCING MUCUS DAILY. IT IS UNKNOWN WHAT MEDICAL INTERVENTION HAS BEEN RECEIVED BY THE PATIENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Nodule
MAUDE report 12602228 ↗MalfunctionOct 8, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A SORE THROAT WITH MUCOUS AND INFLAMMATION. THE PATIENT DID RECEIVE MEDICAL INTERVENTION RESULTING IN PRESCRIBED MEDICATIONS. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Pharyngitis; Sore Throat
MAUDE report 12599641 ↗MalfunctionOct 4, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12570066 ↗InjuryOct 1, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP DECREASED LUNG FUNCTION. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Unspecified Respiratory Problem
MAUDE report 12561976 ↗InjurySep 29, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP SKIN CANCER. THE PATIENT REQUIRED SURGERY IN RESPONSE TO THE REPORTED EVENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Cancer
MAUDE report 12546087 ↗InjurySep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO EXPERIENCE INFECTION OF THE COLON. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF HOSPITALIZATION AND WAS PRESCRIBED ANTIBIOTICS. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Unspecified Infection
MAUDE report 12544900 ↗InjurySep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO EXPERIENCE NOSE BLEEDS, EXACERBATION OF PERIODONTITIS, INFLAMMATION OF THE ROOT TIP, JAW PAIN, HEADACHE, NAUSEA AND LACK OF APPETITE. THE PATIENT UNDERWENT TOOTH EXTRACTION AS A RESULT OF PERIODONTITIS. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Decreased Appetite; Epistaxis; Erosion; Headache; Inflammation; Nausea; Pain
MAUDE report 12543991 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Headache; No Clinical Signs, Symptoms or Conditions
MAUDE report 12543987 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12543980 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12543616 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12543615 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12543612 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12543608 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP EPISTAXIS, HEADACHES, NAUSEA AND TOOTH LOSS. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Epistaxis; Headache; Nausea
MAUDE report 12542342 ↗MalfunctionSep 28, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER (B)(4).
Patient problems: Cough; Dizziness; Fatigue; Headache; No Clinical Signs, Symptoms or Conditions
MAUDE report 12540724 ↗InjurySep 27, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP CANCER. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Cancer
MAUDE report 12533674 ↗MalfunctionSep 24, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12528280 ↗MalfunctionSep 24, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: Headache; No Clinical Signs, Symptoms or Conditions
MAUDE report 12528210 ↗MalfunctionSep 24, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12528186 ↗MalfunctionSep 24, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12528128 ↗MalfunctionSep 17, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12491222 ↗MalfunctionSep 10, 2021Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455921 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
- REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)117 deaths10,075 reports
- DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)106 deaths5,937 reports
- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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