BiPAP AVAPS BiPAP AVAPS C Series, 25cm, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959022034), received between Sep 19, 2022 and Dec 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K102465); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 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 OUT-OF-BOX FAILURE OF FOAM DEGRADATION IN THE BIPAP AVAPS C-SERIES DEVICE. THE CUSTOMER REPORTEDLY STOPPED USING THE DEVICE WITH RISK TO HIS HEALTH. THERE WERE NO REPORTS OF MEDICAL INTERVENTION. DESPITE THREE GOOD-FAITH EFFORT ATTEMPTS ON (B)(6) 2024, THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906916 ↗
• MalfunctionOct 10, 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 THAT THE PATIENT HAS STOPPED USING THE DEVICE AFTER THE RELEASE OF THE FSN. HE IS CONCERNED ABOUT THE HEALTH RISKS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE PATIENT REQUIRED NO MEDICAL INTERVENTION. DUE TO NO DEVICE INFORMATION BEING PROVIDED, THE EXACT RECALL NUMBER IS UNKNOWN. THE POSSIBLE RECALL NUMBERS ARE Z-1972-2021, Z-1973-2021, AND Z-1974-2021. 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 17902520 ↗
• MalfunctionSep 19, 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 BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING WIDESPREAD RASHES AND RED/SWOLLEN LIPS FOR A YEAR. 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: Rash; Swelling/ Edema

  MAUDE report 15447676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102465. One submission often covers many models, so check the product and lot details in each record.

• Z-1973-2021 · Jun 14, 2021 · Open, Classified
  DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironic