DreamStation DreamStation Auto CPAP w/Humid w/H Tube, AURecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00606959026018), received between May 8, 2019 and May 30, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Contamination; 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 RECEIVED INFORMATION ALLEGING VISUALIZATION OF BLACK PARTICLES NEAR THE AIR OUTLET PORT. THIS DEVICE HAS GONE THROUGH THE REMEDIATION PROCESS WHERE BLACK FOAM IS REPAIRED WITH WHITE SILICONE. THIS IS UNLIKELY TO BE FROM FOAM DEGRADATION. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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

  MAUDE report 22116653 ↗
• MalfunctionSep 9, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO HAVE SINUSITIS. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF A PRESCRIPTION FOR NASAL SPRAY AND SINUS DECONGESTANT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Respiratory Tract Infection

  MAUDE report 12449460 ↗
• MalfunctionSep 8, 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 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441068 ↗
• InjuryAug 24, 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 HEART ATTACK LIKE SYMPTOMS. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Asthma; Unspecified Heart Problem

  MAUDE report 12359171 ↗
• MalfunctionAug 16, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO HAVE CHEST TIGHTNESS. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF A NASAL SPRAY AND AN INHALER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Sneezing; Sore Throat; Unspecified Respiratory Problem

  MAUDE report 12327829 ↗
• MalfunctionAug 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. 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

  MAUDE report 12301675 ↗
• MalfunctionJul 7, 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. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Abdominal Pain; Alteration in Body Temperature; Chest Pain; No Clinical Signs, Symptoms or Conditions; Shaking/Tremors

  MAUDE report 12132687 ↗
• InjuryJun 30, 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 BLOOD CLOT IN THEIR LUNG. THE PATIENT DID RECEIVE MEDICAL INTERVENTION IN THE FORM OF A DOCTOR'S ASSESSMENT AND A PRESCRIBED BLOOD THINNER MEDICATION. THE MANUFACTURER IS ATTEMPTING TO HAVE THE DEVICE RETURNED TO ITS PRODUCT INVESTIGATION LAB. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Embolism/Embolus

  MAUDE report 12091806 ↗
• InjuryJun 25, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN END USER IS INVESTIGATING IF A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE HAS CAUSED A LUMP IN HER THROAT RELATED TO THE SOUND ABATEMENT FOAM. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Nodule

  MAUDE report 12069909 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM AN END USER ALLEGING WHILE USING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE HIS PARTIAL DENTURE PLATE BECAME DISLODGED AND SUBSEQUENTLY REQUIRED SURGERY TO REMOVE THE PARTIAL DENTURE PLATE FROM HIS ESOPHAGUS. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Tissue Damage

  MAUDE report 8591988 ↗