BiPAP A40 ITX3100S21Recalls & reported problems
Respironics, Inc. · BiPAP A40 Pro, Italy · Class 2
All models of BiPAP A40 (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Respironics BiPAP ventilator is a breathing support machine. All 163 of its adverse event reports are malfunctions, with no injuries and no deaths. Most describe electrical faults, and some describe sudden shutdowns or ventilator inoperative alarms. Reports fell from 92 in the prior 12 months to 24 in the last 12 months. Two open recalls name this device: one because it is not labeled for patients with respiratory failure, and one because therapy can stop during an alarm.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 163
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00606959055148), received between Dec 15, 2023 and Sep 16, 2026 — classified as 163 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (151 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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
Device problems
- Electrical /Electronic Property Problem151
- Unexpected Shutdown9
- Failure to Power Up2
- Circuit Failure1
- Computer Software Problem1
- Contamination1
- Device Alarm System1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions163
Recent adverse event reports
The 25 most recent of 163 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785509 ↗MalfunctionMar 20, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650073 ↗MalfunctionMar 20, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650064 ↗MalfunctionMar 20, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650058 ↗MalfunctionMar 4, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513547 ↗MalfunctionMar 4, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513195 ↗MalfunctionMar 4, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513006 ↗MalfunctionMar 4, 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 24510278 ↗MalfunctionMar 4, 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 24510256 ↗MalfunctionMar 4, 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 24510195 ↗MalfunctionMar 4, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507466 ↗MalfunctionMar 3, 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 24503732 ↗MalfunctionMar 3, 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 24503674 ↗MalfunctionFeb 26, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE CONDITION OCCURRED ON A BIPAP A40 PRO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE ASSOCIATE MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461110 ↗MalfunctionFeb 9, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293734 ↗MalfunctionFeb 9, 2026Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO DEVICE HAD 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, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293729 ↗MalfunctionFeb 8, 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 24288254 ↗MalfunctionDec 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property 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 ALARM OCCURRED ON A BIPAP A40 PRO DEVICE. 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 23727219 ↗MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497976 ↗MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497770 ↗MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497769 ↗MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS 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 SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497166 ↗MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS 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 SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496902 ↗MalfunctionNov 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS 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 SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496900 ↗MalfunctionSep 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS COMPLAINT HAS BEEN REVIEWED FOR THE ALLEGATION THAT THE DEVICE WAS ALARMING FOR THE VENTILATOR INOPERATIVE WHILE IN PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY, AND IT WILL BE REPORTED AS A PRODUCT PROBLEM. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, AS THE EVENTS DO NOT MEET THE DEFINITION OF A REPORTABLE SERIOUS INJURY COMPLAINT PER THE FDA REGULATIONS (21 CFR 803) THIS EVENT IS REPORTABLE BECAUSE THE FAILURE COULD AFFECT THE ABILITY OF THE DEVICE TO PROVIDE THERAPY TO PUBLISHED SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER, BUT EVALUATION HAS NOT YET BEGUN. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022797 ↗
Other Ventilator, continuous, minimal ventilatory support, facility use devices
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- BiPAP A40 EEX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls422 reports
- BiPAP A40 DEX3100S13Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls164 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 reports
- BiPAP A40 GBX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death157 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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