BiPAP A40 00 (REF 1116153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00606959042834), received between Mar 23, 2022 and Oct 23, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Degraded” (19 reports).

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

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. Aug 26, 2022Open, Classified

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

   Z-1655-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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. THE DEVICE'S MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515458 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200264 ↗
• 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 13932056 ↗
• 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 KIT WAS DAMAGED, BOTTOM ENCLOSURE WAS 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 13932030 ↗
• MalfunctionMar 25, 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 13907438 ↗
• 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 13894373 ↗
• 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 13894291 ↗
• 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 13893044 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND NOISY BLOWER, DAMAGED INLET FOAM, DAMAGED BOTTOM ENCLOSURE, WARNING LABEL, 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 13892794 ↗
• 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 13892715 ↗
• 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, 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 13892571 ↗
• 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 13872422 ↗
• 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 13869913 ↗
• 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 13868920 ↗
• 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 13863091 ↗
• 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 13863015 ↗
• 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 13863007 ↗
• MalfunctionMar 23, 2022Circuit Failure; Degraded; Circuit Failure; 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 13862702 ↗
• MalfunctionMar 23, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BOTTOM ENCLOSURE WAS BROKEN, INLET FOAM WAS DAMAGED. 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 13862327 ↗
• 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, PCA, 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 13862147 ↗