BiPAP A40 BiPAP A40 Silver Series VentilatorRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00606959039537), received between Jul 27, 2021 and Jul 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Degraded” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. THE DEVICE'S SOUND ABATEMENT FOAM WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, DUST FAIL CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25704661 ↗
• MalfunctionMar 4, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE DEVICE WORKS IN PARAMETERS. THE SOFTWARE WAS UPGRADED WITH THE LATEST VERSION, 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 24507966 ↗
• 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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, 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 24455523 ↗
• 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 (B)(4). 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 20405106 ↗
• 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 20405104 ↗
• MalfunctionSep 25, 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 20305475 ↗
• MalfunctionSep 25, 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 20305239 ↗
• InjuryJul 27, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED SEVERE CHEST PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TWO WEEKS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Chest Pain

  MAUDE report 12229188 ↗