BiPAP A40 00 (REF 1076538)Recalls & reported problems
Respironics, Inc. · BiPAP A40 France · Class 2
Quick summary
This Respironics BiPAP A40 is a bedside breathing machine used in care facilities for patients needing continuous help breathing. The 42 reports for it describe the unit not working as expected: error codes that left the ventilator inoperative, circuit or electronic faults, and foam particles found inside the device. No reports describe a death or an injury. Reports naming this identifier rose sharply, from none in the previous 12 months to 15 in the most recent. No recall on this record names the device.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00606959060302), received between Mar 15, 2022 and Sep 28, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Degraded” (28 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded28
- Circuit Failure1
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Circuit Failure; Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923732 ↗MalfunctionSep 18, 2026Degraded
A BiPAP A40 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 observed foam particles inside the assembly. The foam insulation needs to be replaced 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 service technician also noted tobacco and dirt/dust contamination. No repair was performed. The device was scrapped by the service center after the evaluation was completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813461 ↗MalfunctionMar 31, 2022Degraded; Degraded
A VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE SOUND ABATEMENT FOAM WAS REPLACED FOR REPAIR. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13969535 ↗MalfunctionMar 21, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13840078 ↗MalfunctionMar 21, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13839837 ↗MalfunctionMar 21, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13839807 ↗MalfunctionMar 21, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13839685 ↗MalfunctionMar 19, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND TOBACCO DEGRADATION OBSERVED DURING DEVICE EVALUATION. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13827355 ↗MalfunctionMar 19, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER IS NOISY, TOBACCO DEGRADATION, BLOWER ASSEMBLY, VALVE ASSEMBLY, BOTTOM ENCLOSURE, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, LABEL AND POLLEN FILTER, PCA NEEDS TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13817861 ↗MalfunctionMar 19, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES BLOWER IS NOISY, TOP ENCLOSURE DAMAGED, TOBACCO DEGRADATION, AC/DC CONNECTOR, TOP ENCLOSURE, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, BOTTOM ENCLOSURE, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, POLLEN FILTER NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13817858 ↗MalfunctionMar 18, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, PARTICLE AND WATER CONTAMINATION WAS FOUND. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13807619 ↗MalfunctionMar 18, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, PARTICLE AND WATER CONTAMINATION WAS FOUND. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13807616 ↗MalfunctionMar 18, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, PARTICLE AND WATER CONTAMINATION WAS FOUND AND PARTS WERE REPLACED. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13807532 ↗MalfunctionMar 18, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, PARTICLE CONTAMINATION WAS FOUND. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13807288 ↗MalfunctionMar 18, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND WATER DEGRADATION, DIRT OBSERVED DURING DEVICE EVALUATION. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13803907 ↗MalfunctionMar 17, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES ERROR E-122 AND E-152 LOGGED IN, WATER DEGRADATION, AC/DC CONNECTOR, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801202 ↗MalfunctionMar 17, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES WATER DEGRADATION, ERRORS 88-91-122- BOWER BLOCKED, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY + BOTTOM ENCLOSURE + LABEL + PCA (NO SOUNDING ALARM) NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801200 ↗MalfunctionMar 17, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES AC/DC CONNECTOR DAMAGED AND BLOWER IS NOISY, TOBACCO DEGRADATION, AC/DC CONNECTOR, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, BOTTOM ENCLOSURE, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, POLLEN FILTER NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801196 ↗MalfunctionMar 17, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES ERROR E-84 LOGGED IN AND BLOWER IS NOISY, ENCLOSURE DIRTY, WATER DEGRADATION, PCA, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, TOP BOTTOM ENCLOSURE, KEYPAD, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, POLLEN FILTER NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801195 ↗MalfunctionMar 17, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES NOISY BLOWER AND ERROR E-56 LOGGED IN, WATER DEGRADATION, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, AND RIGHT PANEL ASSEMBLY NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801190 ↗MalfunctionMar 17, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES WATER DEGRADATION, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY NEED TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13801186 ↗MalfunctionMar 17, 2022Degraded; Degraded
A VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED AND DIRT DEGRADATION WAS OBSERVED DURING DEVICE EVALUATION. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13791676 ↗MalfunctionMar 16, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE COMPLAINT INCLUDES WATER DEGRADATION, BLOWER ASSEMBLY, VALVE ASSEMBLY, BLOWER CAP, BLOWER HOUSING, INTERNAL AIR COVER, INTERNAL FOAM,BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY NEEDS TO BE REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13790562 ↗MalfunctionMar 16, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, PARTICLES INSIDE FLOW PATH AND ALL PARTS BLOWER ASSEMBLY, VALVE ASSEMBLY, BOTTOM ENCLOSURE, INTERNAL AIR COVER, INTERNAL FOAM, BLOWER BOX MOUNT, RIGHT PANEL ASSEMBLY, BOTTOM LABEL WAS OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13777443 ↗MalfunctionMar 16, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13777442 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.