BiPAP A40 NDX3100S19Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00606959059092), received between Nov 13, 2023 and Jun 12, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 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 DEFECTIVE EEPROM. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE ISSUE. NO REPAIRS WERE PERFORMED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486985 ↗
• MalfunctionJun 9, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DISCOVERY OF VENTILATOR INOPERATIVE ERROR CODES DURING DEVICE EVALUATION. THIS ISSUE HAS BEEN IDENTIFIED UNDER FSN 2023-CC-SRC-039 AND MAY RESULT IN INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATOR INOPERATIVE ALARM. NO PATIENT HARM OR SERIOUS INJURY WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THE DEVICE WAS NOT IN PATIENT USE AT THE TIME THE ISSUE WAS IDENTIFIED. THE RETURNED BIPAP A40 PRO, ND DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. VISUAL INSPECTION FOUND NO EVIDENCE OF FOAM DEGRADATION. REVIEW OF THE EVENT LOG CONFIRMED A VENTILATOR INOPERATIVE ERROR CODE INDICATING THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING WAS 10 CMH2O OR GREATER FOR 5 SECONDS. BASED ON THE EVALUATION FINDINGS, THE TECHNICIAN RECOMMENDED REPLACEMENT OF THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA) TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE WILL BE SCRAPPED PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447959 ↗
• MalfunctionOct 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ALARMS FOR "NON-FUNCTIONING VENTILATOR" OCCURRED ON A BIPAP A40 PRO, ND DEVICE AND A WHINING FAN SOUND IS HEARD IN STANDBY MODE. 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 HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372175 ↗
• MalfunctionFeb 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "NON-FUNCTIONAL" ALARM OCCURRING ON THE DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE INVESTIGATION HAS NOT YET BEGUN. A FINAL REPORT WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307630 ↗
• MalfunctionJan 29, 2025Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO POWERS OFF WHEN THE DEVICE ALARMS FOR A PRESSURE REGULATION ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE EVALUATED. 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. THE BIPAP A40 PRO (NDX3100S19) 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 21266729 ↗
• MalfunctionNov 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT FUNCTIONING. 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 20795430 ↗
• MalfunctionNov 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT WORKING. 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 20795102 ↗
• MalfunctionOct 9, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR EXPERIENCED A 'NON-FUNCTIONING VENTILATOR' ALARM. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408932 ↗
• MalfunctionSep 26, 2024Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR ALARMED AND WAS NOT FUNCTIONING. 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 REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER, 501K NUMBER: K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313260 ↗
• MalfunctionAug 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ALARM OCCURRED FOR A NON-FUNCTIONING VENTILATOR. 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 19990596 ↗
• MalfunctionNov 13, 2023Electrical /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 SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125307 ↗