BiPAP A30 BiPAP A30 Ventilator w/H Tube Humid, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959039346), received between Oct 1, 2021 and Dec 7, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K113053); 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.

Recalls naming this device

1. May 9, 2025Class IOpen, Classified

   This device does not indicate for use in patients with respiratory failure.

   Z-2036-2025 · Root cause: Device Design · Recall details · FDA record ↗

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 7, 2023Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. IN ADDITION, THERE WERE SECONDARY FINDINGS OF BLOWER AND FLOW CONTAMINATION, (DUST AND DIRT), TOP ENCLOSURE DAMAGE, ERROR CODE E-149. THE FOLLOWING REPAIRS WERE MADE TO THE DEVICE TO REMEDY THE ISSUE, BLOWER, BOX MOUNT, PRESSURE TUBE, FLOW TUBE, PCA, MANIFOLD AND TOP ENCLOSURE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281503 ↗
• MalfunctionOct 31, 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 THE PATIENT IS EXPERIENCING HEADACHES WHILE 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: Headache

  MAUDE report 15699518 ↗
• InjuryOct 1, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP KIDNEY DISEASE. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Cough; Dyspnea; Headache; Unspecified Kidney or Urinary Problem

  MAUDE report 12562873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113053. One submission often covers many models, so check the product and lot details in each record.

• Z-1654-2022 · Aug 26, 2022 · Open, Classified
  Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
• 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
• Z-1958-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
• Z-1957-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use