BiPAP A30 00 (REF 1109594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00606959042728), received between Mar 23, 2022 and Aug 2, 2023 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Degraded” (29 reports).

2 FDA recall records name this device's identifier, 2 still open.

3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 9, 2025Open, Classified

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

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

2. Aug 26, 2022Open, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1654-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2023Degraded; Degraded

  THE MANUFACTURER REASSESSED UPON RETROSPECTIVE REMEDIATION REVIEW THAT THIS COMPLAINT IS REPORTABLE 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 BLOWER AND BOTTOM ENCLOSURE ARE DEFECTIVE AND ERRORS RELATED TO THE CIRCUIT BOARD. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. ON JUN-03-2016, A DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. DURING THE EVALUATION OF THE DEVICE, THE MANUFACTURER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DAMAGE. IN ADDITION, THERE WAS AN ERROR WITH THE SYSTEM CIRCUIT BOARD, THE BLOWER DUE TO NOISE, AND THE BOTTOM ENCLOSURE WAS BROKEN. THESE PARTS WERE REPLACED TO ADDRESS THE ISSUE. THE CUSTOMER'S COMPLAINT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439849 ↗
• MalfunctionAug 10, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED AND THE MANUFACTURER HAS CONFIRMED OF DEFECTIVE BLOWER AND BOTTOM ENCLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200247 ↗
• MalfunctionApr 17, 2022Degraded; Degraded

  A VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE SOUND ABATEMENT FOAM WAS REPLACED FOR REPAIR. 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 14132235 ↗
• MalfunctionApr 16, 2022Degraded; Degraded

  A VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE SOUND ABATEMENT FOAM WAS REPLACED FOR REPAIR. 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 14125818 ↗
• MalfunctionMar 28, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER MAKING NOISE, INLET FOAM AND BOTTOM ENCLOSURE WERE BROKEN. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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 13932208 ↗
• MalfunctionMar 28, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER MAKING NOISE, FOAM AND BOTTOM ENCLOSURE WERE BROKEN. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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 13932044 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS 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 13894448 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION BLOWER DAMAGE WAS FOUND. THERE WAS NO REPORT OF SERIOUS 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 13894445 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS 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 13894411 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

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

  MAUDE report 13893000 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES THE BLOWER IS DEFECTIVE.THE DEVICE WAS RETURNED AND NOISY BLOWER, DAMAGED INLET FOAM, DAMAGED BOTTOM ENCLOSURE WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13892790 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES BLOWER AND BOTTOM ENCL. DAMAGED. THE DEVICE WAS RETURNED AND NOISY BLOWER, DAMAGED INLET FOAM, DAMAGED BOTTOM ENCLOSURE, DAMAGED WARNING LABEL WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13892782 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES THE BLOWER IS DEFECTIVE. THE DEVICE WAS RETURNED AND NOISY BLOWER, DAMAGED INLET FOAM, DAMAGED BOTTOM ENCLOSURE, PCA WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13892684 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES THE BLOWER IS DEFECTIVE. THE DEVICE WAS RETURNED AND NOISY BLOWER, DAMAGED FOAM KIT, DAMAGED BOTTOM ENCLOSURE WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13892614 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

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

  MAUDE report 13872369 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

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

  MAUDE report 13872226 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

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

  MAUDE report 13872222 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

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

  MAUDE report 13872219 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES THE BLOWER IS DEFECTIVE. THE DEVICE WAS RETURNED AND DAMAGED BLOWER, BOTTOM ENCLOSURE, WARNING LABEL, INLET FOAM WERE OBSERVED AND CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13870049 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED. THE NOISY BLOWER, DAMAGED BOTTOM ENCLOSURE, INLET FOAM, PCA WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13869889 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES THE BLOWER IS DEFECTIVE. THE DEVICE WAS RETURNED AND CUSTOMER COMPLAINT CONFIRMED. THE NOISY BLOWER, BOTTOM ENCLOSURE, INLET FOAM WERE CHANGED DURING DEVICE EVALUATION. THERE WAS NO REPORT 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 13869862 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER MAKING NOISE, INLET FOAM AND BOTTOM ENCLOSURE WERE BROKEN. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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 13869176 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER MAKING NOISE, INLET FOAM AND BOTTOM ENCLOSURE WERE BROKEN. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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 13869118 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER MAKING NOISE,INLET FOAM WAS DAMAGED, BOTTOM ENCLOSURE WERE BROKEN. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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 13868916 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

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

  MAUDE report 13863106 ↗

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-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
• 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 Respiron