System One System One Heated Tube Humidifier, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00606959032132), received between Sep 6, 2023 and Oct 28, 2025 — classified as 1 death, 8 injuries, 1 malfunction.

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.

• DeathOct 28, 2025Contamination; Contamination

  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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGING KIDNEY DISEASE/TOXICITY, DEATH, HEART FAILURE AND LUNG FAILURE. THERE WAS REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER OBSERVED A BLACK SUBSTANCE, CONSISTENT WITH SOUND ABATEMENT FOAM DEGRADATION, WAS OBSERVED ON THE OUTSIDE BOTTOM OF THE BLOWER BOX AND WAS STUCK TO IT. PRODUCT INVESTIGATION LABORATORY WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. NINE ERRORS WERE LOGGED. DUST LIKE CONTAMINATION AT THE AIR INLET, ON THE PCA, IN THE BLOWER BOX AND THROUGHOUT THE INSIDE ENCLOSURE. PRODUCT INVESTIGATION LABORATORY CAN CONFIRM THE PRESENCE OF MULTIPLE CONTAMINANTS THAT ARE NOT CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM FROM THE SECONDARY FINDINGS. PROD

  Patient problems: Heart Failure/Congestive Heart Failure; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 23402599 ↗
• InjuryAug 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 MANUFACTURER RECEIVED INFORMATION ALLEGING EYE IRRITATION, SKIN IRRITATION, DIZZINESS AND/OR HEADACHE, HYPERSENSITIVITY, NAUSEA / VOMITING, ASTHMA (NEW OR WORSENING) LUNG DISEASE, OTHER,COPD- DRY EYE DROPS , IRRIGULAR HEART BEAT. 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: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Dizziness; Dry Eye(s); Eye Irritation; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Unspecified Heart Problem; Unspecified Respiratory Problem

  MAUDE report 19918752 ↗
• InjuryJul 25, 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 KIDNEY DISEASE, LIVER DISEASE, AND CANCER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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: Cancer; Unspecified Hepatic or Biliary Problem; Unspecified Kidney or Urinary Problem

  MAUDE report 19823880 ↗
• InjuryJun 20, 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 REPORTER ALLEGED OF HAVING KIDNEY DISEASE/TOXICITY. 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: Unspecified Kidney or Urinary Problem

  MAUDE report 19576143 ↗
• InjuryMay 16, 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 ASTHMA (NEW OR WORSENING). 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

  MAUDE report 19337701 ↗
• InjuryMay 2, 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 ASTHMA (NEW OR WORSENING). 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

  MAUDE report 19235585 ↗
• InjuryMay 2, 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 ASTHMA WHILE USING THE DEVICE. 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

  MAUDE report 19234399 ↗
• InjuryFeb 22, 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 RESPIRATORY TRACT IRRITATION,ASTHMA,LUNG DISEASE. 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: Asthma; Unspecified Respiratory Problem

  MAUDE report 18758237 ↗
• InjuryDec 28, 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 EYE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, KIDNEY DISEASE/TOXICITY, LUNG DISEASE AND CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

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

  MAUDE report 18407510 ↗
• MalfunctionSep 6, 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 THE DEVICE IS NOT USING WATER WITH THE LIGHT FLASHING. THE PATIENT ALLEGES THEY ARE WAKING UP DRY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. MEDICAL INTERVENTION WAS NOT SPECIFIED. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Dry Mouth

  MAUDE report 17691818 ↗