BiPAP A40 BiPAP A40 Ventilator, AURecalls & reported problems
Respironics, Inc. · BiPAP A40 Ventilator, Australia · Class 2
All models of BiPAP A40 (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959021549), received between May 3, 2022 and Jun 2, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Degraded” (2 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 18, 2026.
Most reported problems
Device problems
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Respiratory Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE CAREGIVER ALLEGED A RESPIRATORY ILLNESS WHILE USING THE DEVICE. PATIENT ALSO ALLEGED PARTICULATES IN THE CIRCUIT. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Unspecified Respiratory Problem
MAUDE report 14573155 ↗MalfunctionMay 3, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED THE FILTERS ARE TURNING BLACK MORE RAPIDLY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14269701 ↗
Other VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE devices
- Philips Respironics V60Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use3 recalls30 deaths13,525 reports
- PHILIPS 1076716Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death2,946 reports
- PHILIPS 1076709Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use8 deaths2,174 reports
- PHILIPS 1053614Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls4 deaths1,203 reports
- 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
- BiPAP A40 ITX3100S21Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls163 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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