DreamStation DreamStation CPAP with Humidifier, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00606959026537), received between Aug 31, 2021 and Dec 30, 2024 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Degraded” (19 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Degraded; Degraded

  THIS COMPLAINT HAS BEEN REVIEWED AND IT HAS BEEN DETERMINED THAT THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER AND FOAM WAS OBSERVED IN DEVICE. ERROR CODE ALSO PRESENT. THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, HOWEVER THE REPORTED ISSUE/EVENT IS REPORTABLE DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IDENTIFIED IN CAPA PR7211, IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037164 ↗
• MalfunctionDec 30, 2024Degraded; Degraded

  THIS COMPLAINT HAS BEEN REVIEWED AND IT HAS BEEN DETERMINED THAT THE DEVICE WAS RETURNED TO THE THIRD PARTY SERVICE CENTER AND VISIBLE FOAM DEGRADATION WAS OBSERVED IN DEVICE .THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, HOWEVER THE REPORTED ISSUE/EVENT IS REPORTABLE DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IDENTIFIED IN CAPA PR7211, IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036544 ↗
• MalfunctionDec 3, 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. THERE WAS NO HARM OR INJURY REPORTED. THE DREAMSTATION CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE FOUND WITHIN THE DEVICE AND THE COMPLAINT WAS NOT CONFIRMED. THE DEVICE WAS SCRAPPED FOLLOWING THE EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834439 ↗
• MalfunctionSep 11, 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 BLACK PARTICLES BLOWING OUT FROM THE DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 20196256 ↗
• MalfunctionMar 30, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED HEADACHE, NOSE AND SKIN IRRITATION. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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; Skin Inflammation/ Irritation

  MAUDE report 13952180 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF 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 13866848 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE 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 13865032 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE 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 13864753 ↗
• MalfunctionMar 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED CONGESTION, COUGH, AND NASAL/THROAT IRRITATION. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Cough; Nasal Obstruction; Sore Throat

  MAUDE report 13825736 ↗
• MalfunctionJan 6, 2022Degraded; 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 13176870 ↗
• MalfunctionDec 22, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A 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: Asthma; Cough; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061033 ↗
• MalfunctionDec 22, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A 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 13061020 ↗
• InjuryDec 2, 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 A SEVERE LUNG INFECTION. 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: Unspecified Respiratory Problem

  MAUDE report 12916113 ↗
• MalfunctionNov 24, 2021Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO EXPERIENCE EYE SWELLING. THE PATIENT RECEIVED MEDICAL INTERVENTION IN THE FORM OF EYE DROPS. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 12867046 ↗
• MalfunctionNov 15, 2021Contamination; Degraded; Contamination; 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 PREVIUOSLY RECEIVED INFORMATION ALLEGING HAD TO GO TO EMERGENCY TO HAVE THROAT CLEARED RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING PARTICLES IN THE DEVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12809817 ↗
• MalfunctionOct 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 (B)(4).

  Patient problems: Dyspnea; Headache; No Clinical Signs, Symptoms or Conditions; Respiratory Tract Infection; Skin Inflammation/ Irritation; Sleep Dysfunction

  MAUDE report 12711395 ↗
• InjuryOct 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 RES 88058.

  Patient problems: Asthma; Cough; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710982 ↗
• MalfunctionSep 1, 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 12407253 ↗
• MalfunctionAug 31, 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: Cough; No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 12391305 ↗