BiPAP A40 00 (REF 1109598)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959042766), received between Jan 23, 2026 and Feb 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 26, 2022Open, Classified

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

   Z-1655-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Degraded

  THE MANUFACTURER WAS CONTACTED 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 WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED. THE DEVICE HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468530 ↗
• MalfunctionJan 26, 2026Degraded

  A BIPAP A40 VENTILATOR 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 WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION AT THE MANUFACTURER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS REMEDIATED, AND THE FOAM INSULATION NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. THE DEVICE WILL BE SCRAPPED; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183943 ↗
• MalfunctionJan 23, 2026Electrical /Electronic Property Problem; Unexpected Shutdown

  A BIPAP A40 VENTILATOR WAS RETURNED TO A SERVICE CENTER FOR REMEDIATION. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING (REBOOTS OCCURRED WITHIN 24 HOURS) WAS CONFIRMED IN THE EVENT LOG. NO REPAIR WAS PERFORMED. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159532 ↗
• MalfunctionJan 23, 2026Electrical /Electronic Property Problem; Device Sensing Problem; Pressure Problem

  A BIPAP A40 VENTILATOR WAS RETURNED TO A SERVICE CENTER FOR REMEDIATION. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING (THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5) WAS CONFIRMED IN THE EVENT LOG. NO REPAIR WAS PERFORMED. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159531 ↗