BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 60 Series, DERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00606959029682), received between Jan 5, 2022 and May 3, 2026 — classified as 1 death, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Degraded” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Degraded

  A BIPAP AUTO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062572 ↗
• MalfunctionFeb 19, 2026Degraded

  A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY. IN ADDITION, TOBACCO CONTAMINATION WAS FOUND. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385628 ↗
• MalfunctionFeb 13, 2026Degraded

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE DETERIORATED FOAM PARTICLES WERE OBSERVED. THE THIRD PARTY SERVICE CENTER FOUND THE EVIDENCE OF CONTAMINATION OF DUST/DIRT. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED AND THE DEVICE WAS CORRODED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337632 ↗
• MalfunctionJul 22, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED/SCRAPPED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566523 ↗
• MalfunctionAug 15, 2024Degraded; No Apparent Adverse Event; Degraded; No Apparent Adverse Event

  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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND HAS NO VISUALIZATION OF FOAM PARTICLES. IN ADDITION TO ABOVE FINDINGS, THERE WAS A PRESENT OF CONTAMINATION IN THE DEVICE, WHICH IS DUST/DIRT. THERE WAS ALSO A PRESENT OF ERROR CODE, WHICH IS #32. THE DEVICE WAS ROUTED TO SCRAP. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Cough

  MAUDE report 19988869 ↗
• MalfunctionAug 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 DEVICE WAS RETURNED AND EVALUATED BY THE SERVICE CENTER. THE INTERNAL PART OF THE DEVICE WAS INSPECTED VISUALLY AND FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS BEEN SCRAPPED. 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. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE SERVICE CENTER AND NO ERROR WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931641 ↗
• MalfunctionJul 14, 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 DEVICE WAS RETURNED AND EVALUATED BY THE SERVICE CENTER. THE INTERNAL PART OF THE DEVICE WAS INSPECTED VISUALLY AND FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS BEEN SCRAPPED. 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. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE SERVICE CENTER AND NO ERROR WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737568 ↗
• MalfunctionJul 14, 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 DEVICE WAS RETURNED AND EVALUATED BY THE SERVICE CENTER. THE INTERNAL PART OF THE DEVICE WAS INSPECTED VISUALLY AND FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS BEEN SCRAPPED. 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. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE SERVICE CENTER AND NO ERROR WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737561 ↗
• MalfunctionJun 16, 2024Degraded; Degraded

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WAS OBSERVED, TOBACCO CONTAMINATION AND DUST/DIRT WAS PRESENT. FURTHER, THE DEVICE WAS SCRAPPED. THE DEVICE'S EVENT LOG WAS REVIEWED BY THE SERVICE CENTER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544874 ↗
• MalfunctionApr 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 AN ISSUE RELATED TO A BIPAP AUTOSV ADV DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED PARTICLES IN THE AIR PATH DURING THE DEVICE EVALUATION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205237 ↗
• MalfunctionMay 24, 2022Contamination; Degraded; Contamination; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING A HEAVILY SOILED DEVICE, POLLUTION IN THE AIR INTAKE, LOW PRESSURE ERROR MESSAGE, BLACK SOOT IN THE NOSE. 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: Epistaxis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489685 ↗
• MalfunctionMay 20, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING PARTICLES IN THE AIR PATH. 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 14462797 ↗
• InjuryMar 4, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED AN IMMUNE SYSTEM DEFICIENCY. THE PATIENT DID NOT REPORT TO RECEIVE ANY MEDICAL INTERVENTION. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Immunodeficiency

  MAUDE report 13667133 ↗
• MalfunctionMar 4, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING SHORTNESS OF BREATH AND THROAT ISSUES. THERE WAS NO REPORT OF 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: Dyspnea; Sore Throat

  MAUDE report 13667131 ↗
• DeathJan 5, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP BONE CANCER. THE PATIENT EXPIRED IN RESPONSE TO THE REPORTED EVENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Cancer

  MAUDE report 13169662 ↗