REMstar System One 60 Series REMstar Auto A-Flex, w/H Tube Humid, 60 Series, AURecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00606959005488), received between Aug 11, 2021 and Apr 3, 2025 — classified as 8 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Degraded” (40 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 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 THYROID ISSUES, DIZZINESS, AND "FALLING OVER". THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT 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: Dizziness; Hypothyroidism

  MAUDE report 21762948 ↗
• MalfunctionJan 27, 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 AN ISSUE RELATED TO A REMSTAR AUTO A-FLEX DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF BLACK PARTICLES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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 21242221 ↗
• InjuryJan 21, 2025Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED REGARDING THE VOLUNTARY FIELD SAFETY NOTICE/RECALL CONCERNING THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT HAS BEEN DIAGNOSED WITH LIVER DISEASE AND BELIEVES THE CONDITION IS RELATED TO THE USE OF THE DEVICE. THE PATIENT IS SEEKING COMPENSATION AND HAS INDICATED THE INTENTION TO JOIN A CLASS ACTION LAWSUIT IF THEIR REQUEST IS NOT ADDRESSED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 21197129 ↗
• MalfunctionJan 7, 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 THAT THE PATIENT ALLEGING REACTIONS FROM USING THE AFFECTED DEVICE LIKE WATERY EYES, MORE MUCUS THAN NORMAL AND WAKING IN THE REPORTED. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

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

  MAUDE report 21090959 ↗
• MalfunctionOct 4, 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 ALLEGED VISUALIZATION OF BLACK PARTICLES COMING UP OUT OF THE MOUTHPIECE, AND FINE PEPPERY BLACK PARTICLES WHEN BLOWING THEIR NOSE. THE PATIENT STATED THEY ARE "HAVING A NOSE OPERATION DUE TO THE BLACK PARTICLES PICKED UP BY THE SPECIALIST PATIENT ONLY NOTICED THE BLACK PARTICLES WHEN IT STARTED APPEARING ON THE HANDKERCHIEF AND PATIENT ASSUMED IT MIGHT HAVE BEEN THE FILTER". THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 20372521 ↗
• MalfunctionDec 20, 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 IN THE AIR PATH. 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 18370228 ↗
• MalfunctionApr 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING LEFT EYE IRRITATION. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE PATIENT HAS REPORTED TO HAVE SEEN AN OPTOMETRIST AND IS CURRENTLY USING EYE DROPS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Eye Irritation

  MAUDE report 16832040 ↗
• MalfunctionApr 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 MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING A COUGH AND SORE THROAT. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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: Sore Throat

  MAUDE report 16819840 ↗
• MalfunctionNov 14, 2022Degraded; 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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING BLACK PARTICLES IN THE DEVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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 15789824 ↗
• InjuryNov 10, 2022Degraded; 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 SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED HOLES IN THE NASAL SEPTUM. THE PATIENT DID REPORT TO RECEIVE MEDICAL INTERVENTION AND HAS USED NASAL PILLOWS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Perforation

  MAUDE report 15773069 ↗
• MalfunctionNov 7, 2022Degraded; 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 SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED LUNG ISSUES AND A LUNG NODULE. THE PATIENT DID REPORT TO RECEIVE MEDICAL INTERVENTION AND WAS HOSPITALIZED. 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 15745243 ↗
• MalfunctionNov 4, 2022Degraded; 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/MATTER EXPELLING FROM THE DEVICE. 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 15736582 ↗
• InjuryOct 17, 2022Degraded; 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 COPD, SLEEP APNEA, AND HEART FAILURE WHILE USING THE DEVICE. 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: Chronic Obstructive Pulmonary Disease (COPD); Heart Failure/Congestive Heart Failure; Sleep Dysfunction

  MAUDE report 15614625 ↗
• MalfunctionSep 29, 2022Degraded; 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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING BLACK PARTICLES IN THE TUBE AND MASK AFTER COUGHING. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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 15503807 ↗
• MalfunctionSep 29, 2022Degraded; 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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING BLACK PARTICLES IN THE TUBE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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 15503798 ↗
• MalfunctionSep 6, 2022Degraded; 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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING GRAY FLOATING BITS IN THE WATER AND THE DEVICE IS NOSIER THAN USUAL. THE PATIENT HAS ALLEGED TO EXPERIENCING A NASAL INFECTION FOR A FEW WEEKS. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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: Respiratory Tract Infection

  MAUDE report 15364210 ↗
• MalfunctionSep 1, 2022Degraded; 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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING BLACK PARTICLES IN THE MASK. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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 15340703 ↗
• MalfunctionSep 1, 2022Degraded; 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 SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING BLACK PARTICLES IN THE HUMIDIFIER AND THE HEAT PLATE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION 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 15340423 ↗
• MalfunctionAug 16, 2022Degraded; 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 IN THE TUBING. PATIENT ALSO ALLEGED BEING TIRED DUE TO THE DEVICE'S POOR PERFORMANCE AND THAT THE DEVICE IS NOISY. 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: Fatigue

  MAUDE report 15233779 ↗
• MalfunctionJul 26, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM . THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES IN THE TUBE THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT 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 15100811 ↗
• InjuryJul 20, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED A COUGH, CHEST PAIN, A HEART ATTACK, AND A SWOLLEN STERNUM WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS HOSPITALIZATION. 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; Cardiac Arrest; Chest Pain; Cough

  MAUDE report 15064375 ↗
• MalfunctionJul 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM . THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT 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 15061460 ↗
• MalfunctionJun 10, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT 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 14652659 ↗
• MalfunctionJun 10, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT 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 14652658 ↗
• MalfunctionJun 10, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES WERE NOTICED FROM DEVICE AND HUMIDIFIER AND ALSO ALLEGED SINUS ISSUE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT 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: Respiratory Tract Infection

  MAUDE report 14652386 ↗