System One Humidifier System One REMstar Heated HumidifierRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00606959004108), received between Feb 8, 2024 and Jan 20, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Degraded” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K091319); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 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 EYE IRRITATION, NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, AND REDUCED CARDIOPULMONARY RESERVE. 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: Dizziness; Eye Irritation; Headache; Hypersensitivity/Allergic reaction; Unspecified Heart Problem; Unspecified Respiratory Problem

  MAUDE report 21189730 ↗
• InjuryOct 18, 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 DVT (DEEP VEIN THROMBOSIS) WITH THE LEG SWELLING DRAMATICALLY AND LEG PAIN SO INTENSE THE PATIENT COULD BARELY WALK. MEDICAL INTERVENTION WAS SPECIFIED AS BEING PRESCRIBED BLOOD THINNERS FOR 6 MONTHS DURING WHICH TIME THE LEG OF THE PATIENT SLOWLY RETURNED TO NORMAL. THE PATIENT CLAIMED TO HAVE USED THE DEVICE FOR OVER 5 YEARS AND SUSPENDED USE UPON HEARING OF THE RECALL. THE DVT OCCURRED WITHIN ONE MONTH OF SUSPENDING USE OF THE DEVICE. APPROXIMATELY 13 MONTHS LATER (DATE NOT SPECIFIED), THE PATIENT EXPERIENCED ANOTHER DVT AFTER INJURING THE LEG WHILE MOVING FURNITURE. THE PATIENT WAS SUBSEQUENTLY RECOMMENDED TO REMAIN ON BLOOD THINNERS INDEFINITELY. THE PATIENT HAD UNSPECIFIED TESTS PERFORMED TO ATTEMPT TO DETERMINE THE CAUSE OF THE DVT, BUT TESTING WAS UNSUCCESSFUL IN DIAGNOSING THE CAUSE. THE PATIENT CLAIMS TO HAVE NO PERSONAL OR FAMILY HISTORY OF CLOTS, AND ATTRIBUTES THE EVENTS AS OCCURRING FOLLOWING THE SUSPENSION OF USE OF THE DEVICE

  Patient problems: Limb Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20480490 ↗
• InjuryJun 25, 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 LUNG DISEASE (UNSPECIFIED) AND PULMONARY FIBROSIS. 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: Fibrosis; Unspecified Respiratory Problem

  MAUDE report 19609732 ↗
• InjuryApr 29, 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 NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, AND CANCER. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cancer

  MAUDE report 19209927 ↗
• InjuryApr 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 CARDIAC INJURIES, NOSE AND RESPIRATORY TRACT IRRITATION. 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: Cardiac Arrest; Respiratory Tract Infection

  MAUDE report 19119048 ↗
• 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 MANUFACTURER RECEIVED INFORMATION ALLEGES CHRONIC BRONCHITIS AND HEART DISEASE. 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: Bronchitis; Unspecified Heart Problem

  MAUDE report 18852741 ↗
• 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 MANUFACTURER RECEIVED INFORMATION ALLEGES RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, KIDNEY DISEASE/ TOXICITY 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; Dizziness; Headache; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 18852663 ↗
• InjuryFeb 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. THE MANUFACTURER RECEIVED INFORMATION ALLEGING CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR 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: Cancer

  MAUDE report 18670948 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091319. One submission often covers many models, so check the product and lot details in each record.

• Z-1974-2021 · Jun 14, 2021 · Open, Classified
  SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide