BiPAP A40Recalls & reported problems across all models

We found 37 models of BiPAP A40 by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 1,606 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2016 and Sep 30, 2026 — classified as 7 deaths, 9 injuries, 1,590 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1,147 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BiPAP A40 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 9, 2025Open, Classified

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

   Z-2037-2025 · Root cause: Device Design · names 16 of these models · 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 · names 24 of these models · Recall details · FDA record ↗

3. Aug 26, 2022Open, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1655-2022 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗

Most reported BiPAP A40 problems

BiPAP A40 models

37 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BiPAP A40 EEX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls422 reports
• BiPAP A40 DEX3100S13

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls164 reports
• BiPAP A40 ITX3100S21

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls163 reports
• BiPAP A40 GBX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls1 death157 reports
• BiPAP A40 CAX3100S12

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls100 reports
• BiPAP A40 00

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  2 recalls2 deaths98 reports
• BiPAP A40 FRX3100S14

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls50 reports
• BiPAP A40 BiPAP A40 Silver Series Ventilator, JP

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  136 reports
• BiPAP A40 00

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  1 recall2 deaths81 reports
• BiPAP A40 INX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls1 death24 reports
• BiPAP A40 GBX3100H19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls1 death19 reports
• BiPAP A40 BLX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls19 reports
• BiPAP A40 IAX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls16 reports
• BiPAP A40 AUX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls13 reports
• BiPAP A40 ESX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls9 reports
• BiPAP A40 CAX3100T12

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls8 reports
• BiPAP A40 INX3100H19

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls1 report
• BiPAP A40 BiPAP A40 Pro, AR

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls0 reports
• BiPAP A40 00

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  1 recall20 reports
• BiPAP A40 00

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  1 recall4 reports
• BiPAP A40 00

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  1 recall3 reports
• BiPAP A40 DEX3000S13

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall1 report
• BiPAP A40 INX3000H19

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 GBX3000S19

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 ESX3000S19

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 AUX3000S19

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 EEX3000S19

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 FRX3000S14

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 ITX3000S21

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall0 reports
• BiPAP A40 BiPAP A40 Ventilator, FR

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  39 reports
• BiPAP A40 00

  Ventilator, continuous, minimal ventilatory support, facility use
  29 reports
• BiPAP A40 NDX3100S19

  Ventilator, continuous, minimal ventilatory support, facility use
  11 reports
• BiPAP A40 BiPAP A40 Silver Series Ventilator

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  8 reports
• BiPAP A40 00

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  6 reports
• BiPAP A40 BiPAP A40 Ventilator, AU

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  2 reports
• BiPAP A40 BiPAP A40 Ventilator w/H Tube Humid, CA

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  2 reports
• BiPAP A40 BiPAP A40 Sapio Belife

  VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
  1 report

Recent BiPAP A40 adverse event reports

The 15 most recent reports across all models, 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, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BiPAP A40 Pro device was returned to a third-party service center for evaluation. During evaluation of the device, a ¿ventilator inoperative¿ condition/error code 86 related to failure of the outlet pressure sensor was identified. There was no reported harm or injury.During further evaluation at the third-party service center, the recommended repair was replacement of the PCA board. However, the customer requested that the device be scrapped, and the device was not repaired.The evaluation of the device data also identified error codes unrelated to the reportable malfunction. 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.Due to a high internal O2 error E-228, PCA is faulty. E-228 is applicable for FCO00000002. This issue has been identified under the FSN 2023-CC-SRC-042. No errors applicable for FCO00000001. Device will be scrapped as per customer request. Based on the available information, there is not enough evidence to indicate this issue is reportable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951675 ↗
• 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, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a ventilator inoperative error code was found on a BiPAP 40 Pro device. The device was not in use on a patient at the time of the occurrence. During the evaluation of the device at third-party service center, the third-party service technician observed the error code, the power fail voltage is outside its valid range of 4.775 to 5.675 for at least ten seconds, in the device's error log. The third-party service technician further evaluated but was not able to determine the cause of the issue for this device. The root cause is not confirmed at this time. The device was scrapped per the customer request. A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed.Additionally, during the service of the device, the system printed circuit assembly needs replaced for another error code, error high internal O2, that was observed on the device's error log. This was unrelated to the reportable malfunction/issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937488 ↗
• MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935332 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934587 ↗
• MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923732 ↗
• 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 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889119 ↗

Other Respironics, Inc. products

• REMstar System One 60 Series92 models · 37,934 reports
• Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
• Philips DreamStation190 models · 32,422 reports
• Trilogy46 models · 21,644 reports · 11 recalls
• Trilogy Evo20 models · 5,473 reports · 12 recalls
• Trilogy 1008 models · 5,088 reports
• BiPAP System One 60 Series40 models · 4,599 reports
• BiPAP autoSV Advanced System One 60 Series19 models · 1,166 reports