BiPAP A40 BiPAP A40 Ventilator, FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00606959039520), received between Mar 17, 2022 and Mar 3, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Degraded” (25 reports).

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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Degraded

  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 THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE OBSERVED. DEVICE HAS BEEN CORRECTED. ADDITIONALLY, NOT RELATED TO THE ISSUE, DUST/DIRT WAS PRESENT AND THE UNIT WORKS WITHIN PARAMETERS; THE SOFTWARE HAS BEEN UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493566 ↗
• MalfunctionFeb 26, 2026Degraded

  A BIPAP A40 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 AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED ALONG WITH DUST/DIRT, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465225 ↗
• MalfunctionDec 3, 2025Degraded; 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 THE THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE UNIT WORKS WITHIN PARAMETERS; THE SOFTWARE HAS BEEN UPDATED. IN ADDITION, DUST/DIRT CONTAMINATION WAS PRESENT. THE UNIT WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708461 ↗
• MalfunctionOct 22, 2025Degraded; Degraded

  THE BIPAP A40 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. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, FOAM PARTICLES WERE FOUND. THE DEVICE'S SOFTWARE WAS UPDATED. ADDITIONALLY, TOBACCO CONTAMINATION WAS OBSERVED. 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 23358791 ↗
• MalfunctionFeb 20, 2025Circuit 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. THE DEVICE'S BOARD WAS REPLACED. 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 21425837 ↗
• MalfunctionFeb 20, 2025Circuit 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 CONFIRMED. THE DEVICE'S BOARD WAS REPLACED. 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 21425832 ↗
• MalfunctionFeb 3, 2025Electrical /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 NOT DUPLICATED. THE DEVICE CALIBRATED AND PASSED ALL THE TESTS. 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 21292259 ↗
• MalfunctionOct 9, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THIS MALFUNCTION IS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH FSN-2023-CC-SRC-039. UPON REVIEW, THIS MALFUNCTION HAS BEEN DEEMED A REPORTABLE MALFUNCTION. THIS MALFUNCTION IF IT WERE TO RECUR COULD RESULT IN PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405101 ↗
• MalfunctionSep 27, 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. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20321500 ↗
• MalfunctionSep 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20321080 ↗
• MalfunctionSep 27, 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. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20320723 ↗
• MalfunctionSep 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313806 ↗
• MalfunctionSep 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311993 ↗
• MalfunctionSep 26, 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. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20311683 ↗
• MalfunctionSep 26, 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. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20310026 ↗
• MalfunctionSep 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20309352 ↗
• MalfunctionSep 24, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20293474 ↗
• MalfunctionSep 24, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20291972 ↗
• MalfunctionAug 4, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NASAL IRRITATION RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Respiratory Tract Infection

  MAUDE report 15165931 ↗
• MalfunctionAug 3, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES THE PATIENT IS HAVING HEADACHES AND COUGH. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cough; Headache

  MAUDE report 15157504 ↗
• MalfunctionMar 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES NOISY BLOWER AND (B)(4) LOGGED IN, WATER DEGRADATION, PCA, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL FOAM, BLOWER BOX MOUNT, AND RIGHT PANEL ASSEMBLY NEED TO BE REPLACED. 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 13817856 ↗
• MalfunctionMar 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES TOBACCO DEGRADATION, BLOWER ASSEMBLY, BLOWER CAP, BLOWER HOUSING, TOP AND BOTTOM ENCLOSURE, KEYPAD, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, POLLEN FILTER NEED TO BE REPLACED. 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 13817854 ↗
• MalfunctionMar 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES WATER DEGRADATION AND (B)(4) LOGGED IN, AC/DC CONNECTOR, BLOWER ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY NEED TO BE REPLACED. 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 13817847 ↗
• MalfunctionMar 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER IS NOISY, TOBACCO DEGRADATION, BLOWER ASSEMBLY, BLOWER CAP, BLOWER HOUSING, TOP AND BOTTOM ENCLOSURE, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, POLLEN FILTER NEED TO BE REPLACED. 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 13817842 ↗
• MalfunctionMar 19, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER IS NOISY, TOBACCO DEGRADATION, BLOWER ASSEMBLY, BLOWER CAP, BLOWER HOUSING, TOP AND BOTTOM ENCLOSURE, KEYPAD, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, POLLEN FILTER NEED TO BE REPLACED. 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 13817841 ↗