BiPAP A40 BLX3100S19Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00606959059122), received between Sep 12, 2024 and Jun 17, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (17 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. 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-2037-2025 · Root cause: Device Design · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING EVALUATION OF THE DEVICE, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E50, IN THE DEVICE'S HISTORY. 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 SERIOUS INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE BIPAP A40 PRO AT A THIRD-PARTY SERVICE CENTER, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E50, INDICATING THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S PCA TO ADDRESS THE ISSUE. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537028 ↗
• MalfunctionJun 10, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING EVALUATION OF THE DEVICE, THE EVENT LOG WAS REVIEWED AND THERE WERE VENTILATOR INOPERATIVE ERROR CODES, E50 AND E208, IN THE DEVICE'S HISTORY. 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 SERIOUS INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE BIPAP A40 PRO AT A THIRD-PARTY SERVICE CENTER, THE EVENT LOG WAS REVIEWED AND THERE WERE VENTILATOR INOPERATIVE ERROR CODES, E50, INDICATING THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS, AND E208, INDICATING THAT THE BLOWER PRESSURE IS >= 60 CM H20 FOR >= 3 SECONDS. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S PCA TO ADDRESS THE ISSUE. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465497 ↗
• MalfunctionMar 12, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A BIPAP A40 DEVICE REGARDING A VENTILATOR INOPERATIVE CONDITION. 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, AND NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587528 ↗
• MalfunctionMar 12, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A BIPAP A30 DEVICE REGARDING A VENTILATOR INOPERATIVE CONDITION. 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, AND NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582259 ↗
• MalfunctionFeb 9, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD A VENTILATOR INOPERATIVE CONDITION AND THE KEYPAD WAS STUCK. 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 24293732 ↗
• MalfunctionJan 12, 2026Electrical /Electronic Property Problem

  A BIPAP A40 VENTILATOR REPORTED TO THE MANUFACTURER TO HAVE HAD A VENTILATOR INOPERATIVE ALARM OCCUR. THERE WAS NO HARM OR INJURY REPORTED. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, THIS EVENT IS REPORTABLE BECAUSE THE FAILURE COULD AFFECT THE ABILITY OF THE DEVICE TO PROVIDE THERAPY TO PUBLISHED SPECIFICATIONS. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE, THE ALLEGED MALFUNCTION IS NOT ABLE TO BE CONFIRMED AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032012 ↗
• MalfunctionOct 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A BIPAP A40 PRO DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE BIPAP A40 PRO DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER. THE SERVICE TECHNICIAN CONFIRMED THE CUSTOMER'S COMPLAINT. A VENTILATOR INOPERATIVE ERROR CODE RELATING TO A PRESSURE FAILURE WAS FOUND IN THE DEVICE'S ERROR, WHICH WAS CAUSED BY A FAULTY PRINTED CIRCUIT ASSEMBLY (PCA) BOARD. THE PCA BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, NON-REPORTABLE PATIENT DISCONNECT, POWER REDUCTION AC DISCONNECTED, COIN CELL VOLTAGE, AC WATTAGE INCORRECT, AND DETACHABLE BATTERY DISCONNECTED ERROR WERE ALSO FOUND IN THE DEVICE'S ERROR LOG. THE AIR PATH WAS REPLACED FOR PREVENTATIVE MAINTENANCE. THE DEVICE PASSED ALL FINAL CHECKS AND TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23284789 ↗
• MalfunctionOct 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A BIPAP A40 PRO DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE BIPAP A40 PRO DEVICE WAS EVALUATED BY A THIRD PARTY SERVICE CENTER. THE SERVICE TECHNICIAN CONFIRMED THE CUSTOMER'S COMPLAINT. A VENTILATOR INOPERATIVE ERROR CODE RELATING TO A PRESSURE FAILURE WAS FOUND IN THE DEVICE'S ERROR. THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, A NON-REPORTABLE LOW CIRCUIT LEAK ALARM WAS ALSO FOUND IN THE DEVICE'S ERROR LOG. THE PCA BOARD REPLACED WILL ALSO RESOLVE THIS ERROR CODE. THE AIR PATH WAS REPLACED FOR PREVENTATIVE MAINTENANCE. THE DEVICE PASSED ALL FINAL CHECKS AND TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281639 ↗
• MalfunctionAug 29, 2025Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem; Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO A VENTILATOR INOPERATIVE CONDITION OCCURRING IN CERTAIN BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION ON THE DEVICE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE¿S AIRPATH KIT WHICH CONTAINS THE MAIN PCA AND BLOWER WAS REPLACED TO ADDRESS THE ISSUE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. ADDITIONALLY, AN ALARM INDICATING A COIN CELL VOLTAGE IS OUT OF RANGE WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S MAIN PCA REPLACEMENT ADDRESSED THIS ISSUE. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. THE BIPAP A40 PRO (BLX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922285 ↗
• MalfunctionAug 27, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER STATING THAT A BIPAP A40 PRO DEVICE WAS INACTIVE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE BIPAP A40 PRO DEVICE WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER. THE DEVICE EVALUATION FOUND A VENTILATOR INOPERATIVE ERROR CODE IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, A NON-REPORTABLE COIN CELL VOLTAGE ERROR CODE WAS ALSO FOUND IN THE DEVICE'S ERROR LOG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906873 ↗
• MalfunctionAug 27, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER STATING THAT A BIPAP A40 PRO DEVICE WAS INACTIVE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE BIPAP A40 PRO DEVICE WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER. THE DEVICE EVALUATION FOUND A VENTILATOR INOPERATIVE ERROR CODE IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE ERROR WAS DUE TO A FAULTY PRINTED CIRCUIT ASSEMBLY (PCA) BOARD. THE PCA BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE AIR PATH KIT WAS REPLACED PREVENTATIVELY. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906620 ↗
• MalfunctionAug 27, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING A DISCONNECTION ISSUE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION A VENTILATOR INOPERATIVE ALARM CONDITION WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE¿S MAIN PCA WAS REPLACED TO ADDRESS THE ISSUE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. ADDITIONALLY, NOT RELATED TO THE ABOVE ISSUE, THE DEVICE'S AIRPATH WAS REPLACED PREVENTATIVELY. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. THE DEVICE WAS SCRAPPED. THE BIPAP A40 PRO (BLX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904746 ↗
• MalfunctionJan 31, 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 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286408 ↗
• MalfunctionDec 5, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854494 ↗
• MalfunctionDec 5, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854233 ↗
• MalfunctionOct 24, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523541 ↗
• MalfunctionOct 2, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S OXYGEN DELIVERY WAS HIGH. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354378 ↗
• MalfunctionOct 2, 2024Circuit Failure; Mechanical Problem; Power Problem; Circuit Failure; Mechanical Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD STOP SPONTANEOUSLY. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353918 ↗
• MalfunctionSep 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (EEX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199772 ↗