BiPAP A40 DEX3100S13Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00606959055186), received between Dec 5, 2023 and Sep 30, 2026 — classified as 1 injury, 163 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (147 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 25 most recent of 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952645 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951007 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950677 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  A Bipap A40 Pro device was returned to a third-party service center for service. There was no serious patient harm or injury that occurred or was reported.During the evaluation at the third-party service center, a ventilator inoperative error code was found in the device's error log stating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. There is no documentation stated on a root cause and/or any component replacement to resolve the issue.No repairs were performed. The device will be scrapped per the customer's request.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945981 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  A Bipap A40 Pro device was returned to a third-party service center for service. There was no serious patient harm or injury that occurred or was reported.During the evaluation at the third-party service center, a ventilator inoperative error code was found in the device's error log stating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. There is no documentation stated on a root cause and/or any component replacement to resolve the issue.No repairs were performed. The device will be scrapped per the customer's request.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945977 ↗
• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BiPAP A40 Pro 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 is no allegation of serious or permanent harm or injury. The device was not documented to be in patient use.During the evaluation of the device, the service technician identified a ventilator inoperative error code E-47 indicating that the "CPU cannot communicate with the pressure sensor using SPI bus." The service technician states that the printed circuit assembly (PCA) board is faulty due to this error code. 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 that these error codes contributed to or caused the reported event. The field service technician identified one of these unrelated error codes as an additional cause of the PCA failure. No repair was performed. The device was scrapped by the service center

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942197 ↗
• MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931462 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916613 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  A BiPAP A40 PROEFL device was returned to a third-party service center for service in relation to 2023-CC-SRC-039. There is no allegation of serious or permanent harm or injury. The device was not documented to be in patient use.During the evaluation at the third-party service center, a ventilator inoperative error code E-50 was found in the device's error log.  This error indicates 'the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. No repairs were performed. The device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896610 ↗
• MalfunctionSep 23, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BIPAP A40 Pro was returned to a third-party service center for service. There was no serious patient harm or injury reported. The device was not in clinical use.During the evaluation of the device at a third-party service center, the device was visually inspected and found no evidence of foam degradation. A ventilator inoperative error code was confirmed in the event log indicating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. The device's main board needs replaced to address the issue. No components were replaced. The device was scrapped per the customer's request.The BIPAP A40 Pro DEX3100S13 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 50869172 ↗
• MalfunctionAug 27, 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 device 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 sugge

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484413 ↗
• MalfunctionJul 7, 2026Circuit Failure

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG STATING THE FAILURE OF THE OUTLET PRESSURE SENSOR. THE SERVICE TECHNICIAN STATES THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD NEEDS TO BE REPLACED TO RESOLVE THE ERROR. ADDITIONALLY, THE DEVICE WAS VISUALLY INSPECTED, AND NO FOAM PARTICLES WERE OBSERVED. NO REPAIRS WERE PERFORMED. THE DEVICE WILL BE SCRAPPED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742823 ↗
• MalfunctionJul 7, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED FROM THE DEVICE DATA THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS (ERROR CODE 50). ERROR CODE 50 IS A VENTILATOR INOPERATIVE CODE AND THE PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS REPLACED TO ADDRESS THIS ERROR CODE. 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 THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738826 ↗
• MalfunctionJul 7, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED FROM THE DEVICE DATA THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS (ERROR CODE 50). ERROR CODE 50 IS A VENTILATOR INOPERATIVE CODE AND THE PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS REPLACED TO ADDRESS THIS ERROR CODE. 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 THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735585 ↗
• MalfunctionJul 6, 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 DEVICE 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 PRINTED CIRCUIT ASSEMBLY (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 EVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718736 ↗
• MalfunctionJul 6, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED FROM THE DEVICE DATA THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS (ERROR CODE 50). ERROR CODE 50 IS A VENTILATOR INOPERATIVE CODE. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. 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 THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718497 ↗
• MalfunctionJul 6, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED FROM THE DEVICE DATA THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS (ERROR CODE 50). ERROR CODE 50 IS A VENTILATOR INOPERATIVE CODE. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. 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 THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717084 ↗
• MalfunctionJul 3, 2026Electrical /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 CONDITION OCCURRED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS SCRAPPED. 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 25704660 ↗
• MalfunctionJul 2, 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, E20, 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 DEVICE AT A THIRD-PARTY SERVICE CENTER, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E20, INDICATING A DEFECTIVE EEPROM. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (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 THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE SERVICE TECHNICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25698115 ↗
• MalfunctionJul 2, 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 DEVICE 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 PRINTED CIRCUIT ASSEMBLY (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 EVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25697178 ↗
• MalfunctionJul 2, 2026Electrical /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 DEVICE 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. THERE WAS NO CAUSE NOTED BY THE SERVICE TECHNICIAN THAT CONTRIBUTED TO THE VENTILATOR INOPERATIVE ERROR CODE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696118 ↗
• MalfunctionJul 2, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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 IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING EVALUATION OF THE BIPAP A40 PRO DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE SERVICE TECHNICIAN NOTED FROM THE DEVICE DATA THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS (ERROR CODE 50). ERROR CODE 50 IS A VENTILATOR INOPERATIVE CODE, HOWEVER, THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE 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 THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693553 ↗
• MalfunctionJul 1, 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 DEVICE 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 PRINTED CIRCUIT ASSEMBLY (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 EVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682321 ↗
• MalfunctionJul 1, 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 DEVICE 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 PRINTED CIRCUIT ASSEMBLY (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 EVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682047 ↗
• MalfunctionJul 1, 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 DEVICE 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 PRINTED CIRCUIT ASSEMBLY (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 EVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680129 ↗