BiPAP S/T C-Series BiPAP S/T C Series, 25cm, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959039094), received between Aug 2, 2021 and Mar 4, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Contamination; Degraded

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN RELATION TO THE VOLUNTARY FIELD SAFETY NOTICE AND RECALL NOTIFICATION INVOLVING THE SOUND ABATEMENT FOAM USED IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION, THE SERVICE CENTER CONDUCTED A VISUAL INSPECTION AND OBSERVED EVIDENCE OF FOAM DEGRADATION, INCLUDING THE PRESENCE OF DUST WITHIN THE DEVICE. THE DEVICE POWERED ON SUCCESSFULLY, AND AIRFLOW FUNCTIONALITY WAS VERIFIED. THE SERVICE CENTER CONCLUDED THAT VISIBLE FOAM DEGRADATION AND DUST WERE PRESENT, AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505103 ↗
• MalfunctionAug 1, 2025Degraded; Degraded

  THIS COMPLAINT HAS BEEN REVIEWED, AND IT HAS BEEN DETERMINED THAT THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. THE EVALUATION RESULT FOUND VISIBLE FOAM PARTICLES INSIDE THE ASSEMBLY. THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, HOWEVER THE REPORTED ISSUE/EVENT IS REPORTABLE DUE TO THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IDENTIFIED IN CAPA PR7211, IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22692728 ↗
• MalfunctionFeb 28, 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 21496957 ↗
• MalfunctionOct 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND EVALUATED. EVALUATION RESULTS FOUND FOAM PARTICLES WERE VISIBLE. THE DEVICE HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437944 ↗
• InjuryAug 2, 2021Degraded; 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 NASAL CONGESTION, FACE IRRITATION, AND NEOPLASMS. THE PATIENT WILL BE RECEIVING RADIOTHERAPY IN RESPONSE TO THE REPORTED EVENT. 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 12258787 ↗

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