BiPAP A40 ESX3100S19Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00606959059368), received between Dec 15, 2023 and Mar 25, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 9, 2025Open, Classified

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

   Z-2037-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 26, 2024Open, Classified

   Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

   Z-1813-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A VENTILATOR INOPERATIVE CONDITION WAS REPORTED ON A BIPAP A40 PRO DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688776 ↗
• MalfunctionNov 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. 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. 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 20795089 ↗
• MalfunctionNov 8, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE OCCURRED WHILE IN PATIENT USE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039 DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER, BUT EVALUATION HAS NOT YET BEGUN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SERVICE CENTER'S INVESTIGATION IS COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645737 ↗
• MalfunctionNov 8, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE OCCURRED WHILE IN PATIENT USE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039 DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER, BUT EVALUATION HAS NOT YET BEGUN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SERVICE CENTER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642451 ↗
• MalfunctionNov 8, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE OCCURRED WHILE IN PATIENT USE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039 DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER, BUT EVALUATION HAS NOT YET BEGUN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SERVICE CENTER'S INVESTIGATION IS COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641665 ↗
• MalfunctionNov 8, 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. THE VENTILATOR WAS RETURNED WITH THE ALLEGATION OF A VENTILATOR INOPERATIVE ALARM HAVING OCCURRED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AS DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. PROBLEM CITED: INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641377 ↗
• MalfunctionFeb 1, 2024Partial Blockage; Contamination; Electrical /Electronic Property Problem; Partial Blockage; Contamination; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT AN INOPERATIVE ALARM OCCURRED ON A VENTILATOR. THERE WAS NO HARM OR INJURY REPORTED. 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 18621089 ↗
• MalfunctionDec 18, 2023Computer Software Problem; Computer Software Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE BIPAP A40 PRO WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS NOT DUPLICATED. ERROR CODE E-96 WAS NOTED IN THE ERROR LOG WHICH ENGINEERING ASSUMED TO BE RELATED TO A SOFTWARE ISSUE. IT WAS ALSO CONFIRMED THAT ERROR CODE E-45 OCCURRED WHILE THERE WAS AN ISSUE WRITING TO SERIAL FLASH. PER ENGINEERING, VIA OBSERVATION OF THE SD CARD CONTENTS THAT SEVERAL MONTHS' WORTH OF COMPLIANCE DATA IS MISSING AS WELL. NO VENTILATOR INOPERATIVE WAS NOTED IN THE ERROR/EVENT LOG BUT WAS NOTED IN THE ALARM LOG. IT WAS CONFIRMED THAT THE DEVICE WORKED AT THE PIL WITH NO ERROR CODES OR ISSUES. PER ENGINEERING THIS EVENT HAS BEEN VERIFIED AS A SOFTWARE ISSUE AND THE EXTENSIVE INVESTIGATION HAS TURNED UP EVIDENCE OF A SERIAL FLASH WRITES FAILING/HANGING. THIS SOFTWARE ISSUE IS BEING FURTHER INVESTIGATED AND THE UNIT IS SCRAPPED AND BEING HELD FOR FURTHER EVALUATED. CURRENTLY A RISK IS BEING ASSESSED AND A CAPA IS CURRENTLY UNDERWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343399 ↗
• MalfunctionDec 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO VENTILATOR INOPERATIVE CONDITION OCCURRED. ERROR CODE E-46 AND E -47 WAS PRESENT. THERE WAS NO HARM OR INJURY REPORTED. 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 18337013 ↗