DreamStation DreamStation Heated Humidifier, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00606959022645), received between Mar 30, 2022 and Nov 11, 2025 — classified as 1 death, 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Degraded” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Degraded; Contamination of Device Ingredient or Reagent; Excessive Heating; Degraded; Contamination of Device Ingredient or Reagent; Excessive Heating

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN DREAM STATION HUMID. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING NASAL, THROAT, EYE IRRITATION AND COUGHING. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, THE MANUFACTURER OBSERVED THE DUST/DIRT AND FIBROUS CONTAMINATION ON THE FLIP LID LOCKING MECHANISM, OUTSIDE OF THE BLOWER BOX, OUTLET ISO PORT OF THE HUMIDIFIER, THE AIR INLET OF THE MOTOR, AND ON THE HEAT PLATE WAS INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM CONTAMINATION. THE FLIP LID LOCKING MECHANISM WAS DAMAGED. THE PRESENCE OF CONTAMINATION WITHIN THE AIRPATH SUGGESTS A SOURCE EXTERNAL TO THE DEVICE. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX AND IT IS CONSISTENT WITH THE KERATIN CONTAMINATION. THE HUMIDIFIER CONTAINED LARGE AMOUNTS OF MINERAL DEPOSITS IN THE WATER CHAMBER AND THERE WAS EVIDENCE OF WATER INGRESS IN

  Patient problems: Cough; Eye Irritation; Unspecified Respiratory Problem

  MAUDE report 23520313 ↗
• MalfunctionOct 27, 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 THAT THE PATIENT ALLEGING UPPER RESPIRATORY INFECTION. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE INSPECTED AND OBSERVED DUST/DIRT CONTAMINATION INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM WAS OBSERVED THROUGHOUT DEVICE ENCLOSURE, AND AIRPATH, SUGGESTING A SOURCE EXTERNAL TO THE DEVICE. SLIGHT BLACK CONTAMINATION AT THE BLOWER SEAL OF THE BLOWER BOX IS CONSISTENT WITH THE KERATIN CONTAMINATION OBSERVED. THE MANUFACTURER WAS NOT OBSERVED THE SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADAT

  Patient problems: Respiratory Tract Infection

  MAUDE report 23391718 ↗
• MalfunctionOct 15, 2025Degraded; 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 PATIENT ALLEGES LUNG NODULE. 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: Nodule

  MAUDE report 23299203 ↗
• MalfunctionJan 30, 2025Excessive Heating; Excessive Heating

  THE NOTIFICATION IS BEING REVIEWED DUE TO A USER OF A DREAMSTATION HUMIDIFIER DEVICE WITH AN ALLEGATION OF POWER SUPPLY ERROR MESSAGE. THE UNIT WOULD ALSO NOT POWER ON. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT REPORTED THE DEVICE WOULD INTERMITTENTLY POWER ON FOR A WHILE, BUT UPON POWERING THE DEVICE OFF, THE POWER SUPPLY ERROR MESSAGE WOULD DISPLAY AGAIN. THE PATIENT PULLED THE POWER CORD OUT OF THE DEVICE AND NOTICED BURN MARKS ON THE MACHINE AND THE POWER CORD (WHERE THE POWER CORD ENTERS THE DEVICE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277109 ↗
• InjuryJan 29, 2025Degraded; 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 PATIENT ALLEGES NOSE IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, KIDNEY DISEASE, AND LIVER DISEASE. 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: Dizziness; Headache; Hypersensitivity/Allergic reaction; Unspecified Hepatic or Biliary Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 21268187 ↗
• InjuryJan 16, 2025Degraded; 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 ASTHMA (NEW OR WORSENING), LUNG DISEASE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Asthma; Unspecified Respiratory Problem

  MAUDE report 21167549 ↗
• InjuryAug 7, 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 CANCER. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer

  MAUDE report 19935776 ↗
• MalfunctionJul 10, 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 IN WATER CHAMBER. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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 19709172 ↗
• InjuryJun 23, 2024Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED ABOUT A VOLUNTARY FIELD SAFETY NOTICE/RECALL RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED REPORTS ALLEGING THAT THE PATIENT EXPERIENCED DIZZINESS, HEADACHE, AND ASTHMA¿NEW OR WORSENING. NO SPECIFIC MEDICAL INTERVENTION WAS MENTIONED. THE MANUFACTURER WAS MADE AWARE OF THIS INFORMATION THROUGH THE CUSTOMER¿S LEGAL REPRESENTATIVE. DUE TO POTENTIAL LEGAL ISSUES SURROUNDING THIS CASE, NO FURTHER INVESTIGATION OR FOLLOW-UP CAN BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Asthma; Dizziness; Headache

  MAUDE report 19591684 ↗
• InjuryMay 17, 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 AN ISSUE RELATED TO A CPAP DEVICE'S HUMIDIFIER SOUND ABATEMENT FOAM. THE PATIENT ALLEGED KIDNEY DISEASE/TOXICITY. MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE PATIENT. DUE TO POTENTIAL LITIGATION SURROUNDING THIS CASE, NO FOLLOW UP CAN BE PERFORMED AT THIS TIME. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 19347117 ↗
• InjuryMay 13, 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 FROM THE PATIENT ALLEGING THAT THE PATIENT HAS EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, NAUSEA, VOMITING, ASTHMA (NEW OR WORSENING)INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, LUNG DISEASE, REDUCED CARDIOPULMONARY RESERVE OTHER HEART ATTACK. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma; Dizziness; Eye Irritation; Headache; Inflammation; Nausea; Skin Inflammation/ Irritation; Unspecified Heart Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem; Vomiting

  MAUDE report 19302475 ↗
• DeathMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A CUSTOMER REQUESTING INFORMATION ON SHIPPING BACK A DREAMSTATION HUMIDIFIER DEVICE DUE TO A PATIENT PASSING AND NOT NEEDING IT ANYMORE. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED FOR AN ALLEGATION OF A PATIENT DEATH ONLY DUE TO INSUFFICIENT INFORMATION RELATED TO THE DEVICE. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Insufficient Information

  MAUDE report 19279704 ↗
• InjuryMar 26, 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 SKIN IRRITATION AND ASTHMA (NEW OR WORSENING). MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE BASE DEVICE INFORMATION WAS NOT RECEIVED, THE HUMIDIFIER SERIAL NUMBER GIVEN IS (B)(6) . THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Asthma; Skin Inflammation/ Irritation

  MAUDE report 18983752 ↗
• InjuryMar 6, 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 PATIENT ALLEGES LUNG DISEASE WHILE USING THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18851724 ↗
• MalfunctionFeb 8, 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. RECEIVED. THE PATIENT HAS ALLEGED VISUALIZATION OF BLACK PARTICLES. 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 18673724 ↗
• MalfunctionJan 26, 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 OF DIZZINESS AND/OR HEADACHE. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND THERE IS NO CONTACT INFORMATION TO GAIN ADDITIONAL INFORMATION ON THE DEVICE. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Dizziness; Headache

  MAUDE report 18590551 ↗
• MalfunctionDec 26, 2023Degraded; 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 PATIENT ALLEGES THAT HIS HUMIDIFIER HAS NOT BEEN HEATING UP OR USING ANY WATER THE PAST FEW WEEKS. PATIENT EXPERIENCED HAVING EXTREMELY DRY MOUTH SO HE HAS DIFFICULTY SLEEPING. 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: Dry Mouth

  MAUDE report 18394786 ↗
• InjuryOct 12, 2023Degraded; 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 PARTICLES. THE PATIENT ALLEGED "MASS ON HIS SMALL INTESTESTENCE" AND "THINKS THIS IS CONNECTED TO THE RECALL". MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 17919704 ↗
• InjuryOct 11, 2023Degraded; 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 PARTICLES. THE PATIENT ALLEGED ""MASS ON HIS SMALL INTESTESTENCE" AND "THINKS THIS IS CONNECTED TO THE RECALL". MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 17915907 ↗
• MalfunctionMar 30, 2022Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND OBSERVE CONTINUE LEVEL ERROR, PARTICLE CONTAMINATION ON BOTTOM ENCLOSURE, TOP ENCLOSURE, AND ON REAR PANEL DURING DEVICE EVALUATION. 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: Cough; Dyspnea; No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 13957229 ↗