REMstar System One 60 Series REMstar Auto, CNRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00606959031142), received between Jul 22, 2021 and Sep 30, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Degraded” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 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 VISUALIZATION OF PARTICLES IN THE AIR PATH. THE PATIENT ALLEGES A FREQUENT COUGH AFTER USING 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: Cough

  MAUDE report 20332387 ↗
• InjuryFeb 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 MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REMSTAR AUTO DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES IN DEVICE. THE PATIENT ALSO ALLEGED TO FOUND ALVEOLAR WHITE SPOTS IN THE LUNGS DURING THE 2019 PHYSICAL EXAMINATION. THERE WAS NO REPORT OF 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: Nodule

  MAUDE report 18737545 ↗
• MalfunctionNov 8, 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 OF HAVING DIZZINESS. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE MANUFACTURE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURE'S INVESTIGATION IS COMPLETE.

  Patient problems: Dizziness

  MAUDE report 18093735 ↗
• MalfunctionOct 17, 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. THE PATIENT ALLEGES HEADACHE AND DIZZINESS. 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 17953758 ↗
• InjurySep 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 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: Cancer

  MAUDE report 17840579 ↗
• MalfunctionJul 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 THE PATIENT SUSPECTS HEADACHES ARE CAUSED SILENT COTTON AND HAS MADE AN APPOINTMENT TO INSPECT DEVICE. THE DISTRIBUTOR PROVIDED A BACTERIA FILTER TO THE USER, BUT USER WILL NOT USE IT. 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: Headache

  MAUDE report 17417750 ↗
• MalfunctionMar 15, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771967 ↗
• MalfunctionMar 15, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771966 ↗
• MalfunctionMar 15, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771964 ↗
• MalfunctionMar 15, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771961 ↗
• InjuryDec 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A NEW USER REPORTED AN UPPER RESPIRATORY TRACT INFECTION AFTER USING HIS CPAP DEVICE FOR 10-15 DAYS. HE RECEIVED AN INJECTION AT HIS HOSPITAL CONSULTATION DUE TO HIS GENERAL DISCOMFORT. AFTER TWO MORE ADDITIONAL TRIALS OF CPAP OF THERAPY FOR 10 DAYS, THE USER EXPERIENCED THE SAME SYMPTOMS, DESPITE HAVING HIS MACHINE CHECKED OUT AND ADJUSTED. HIS PHYSICIAN SUGGESTED TO STOP USING THE DEVICE. THE MANUFACTURER HAS REQUESTED THE RETURN OF THE DEVICE. THE INVESTIGATION IS ON-GOING. ON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Respiratory Tract Infection

  MAUDE report 12931946 ↗
• MalfunctionSep 27, 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 PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537009 ↗
• MalfunctionJul 22, 2021Degraded; Degraded

  THE THIRD-PARTY RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO HAVE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE SOUND ABATEMENT FOAM WAS FOUND TO BE DEGRADED. 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)

  MAUDE report 12213184 ↗