BiPAP A30 00 (REF 1109590)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00606959042698), received between Nov 4, 2025 and Mar 24, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K113053); they may or may not involve this specific model.

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-1654-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT DURING THE EVALUATION OF A BIPAP A30 DEVICE AT A SERVICE CENTER, IT WAS DISCOVERED THAT THERE WAS A VENTILATOR INOPERATIVE ALARM IN THE DEVICE'S ERROR LOG. 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. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR IN THE DEVICE'S HISTORY. THERE WAS NO CAUSE NOTED BY THE SERVICE TECHNICIAN THAT CONTRIBUTED TO THE VENTILATOR INOPERATIVE ERROR. 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. 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 24676693 ↗
• MalfunctionMar 3, 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 SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM DEGRADATION WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500440 ↗
• MalfunctionMar 3, 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 SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, FOAM DEGRADATION WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500010 ↗
• MalfunctionFeb 26, 2026Degraded

  A BIPAP A30 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455521 ↗
• MalfunctionFeb 26, 2026Degraded

  A BIPAP A30 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455520 ↗
• MalfunctionJan 28, 2026Electrical /Electronic Property Problem

  A BIPAP A30 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING THREE REBOOTS OF THE DEVICE OCCURRED WITHIN 24 HOURS WAS CONFIRMED IN THE EVENT LOG. NO COMPONENTS WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203212 ↗
• MalfunctionJan 28, 2026Electrical /Electronic Property Problem

  A BIPAP A30 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, VENTILATOR INOPERATIVE ERROR CODES INDICATING THE CPU CANNOT COMMUNICATE WITH THE FLOW SENSOR AND THE PRESSURE SENSOR, AND INDICATING THE POWER FAIL VOLTAGE IS OUTSIDE ITS VALID RANGE OF 4.775 TO 5.675 FOR AT LEAST 10 SECONDS WERE CONFIRMED IN THE EVENT LOG. NO COMPONENTS WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203211 ↗
• MalfunctionJan 28, 2026Electrical /Electronic Property Problem

  A BIPAP A30 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING THE DEVICE IS UNABLE TO BE OPERATED AFTER THREE RESTARTS WAS CONFIRMED IN THE EVENT LOG. NO COMPONENTS WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202408 ↗
• MalfunctionJan 27, 2026Electrical /Electronic Property Problem

  A BIPAP A30 VENTILATOR WAS RETURNED TO A MANUFACTURER 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 MANUFACTURER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODES INDICATING (CPU CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS) 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 24187301 ↗
• MalfunctionJan 27, 2026Electrical /Electronic Property Problem

  A BIPAP A30 VENTILATOR WAS RETURNED TO A MANUFACTURER 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 MANUFACTURER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODES INDICATING ((THE DEVICE CANNOT BE OPERATED AFTER THREE RESTARTS) 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 24187299 ↗
• MalfunctionJan 27, 2026Electrical /Electronic Property Problem

  A BIPAP A30 VENTILATOR WAS RETURNED TO A MANUFACTURER SERVICE CENTER FOR SERVICE. 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 MANUFACTURER SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODES INDICATING (THE POWER FAIL VOLTAGE IS OUTSIDE ITS VALID RANGE OF 4.775 TO 5.675 FOR AT LEAST 10 SECONDS) 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 24187180 ↗
• MalfunctionJan 26, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  A BIPAP A30 VENTILATOR WAS RETURNED TO A MANUFACTURER SERVICE CENTER FOR SERVICE. 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 THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODES INDICATING (CPU CANNOT COMMUNICATE WITH THE FLOW SENSOR USING I2C BUS AND CPU CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS) WAS CONFIRMED IN THE EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S CIRCUIT BOARD TO ADDRESS THE ISSUE. 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 24180636 ↗
• MalfunctionJan 26, 2026Electrical /Electronic Property Problem

  THE BIPAP A30 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR THE REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, ALTHOUGH THERE WAS NO EVIDENCE OF FOAM DEGRADATION IN THE DEVICE, A CRITICAL ERROR CODE IN RELATION TO (UNIT IS EXCEEDING THE REQUESTED PRESSURE SETTINGS FOR 10 SECONDS. ¿ HIGH PRESSURE SENSOR READING ¿ LARGE AMOUNT OF DRIFT ¿ PINCHED/BLOCKED TUBING SECONDS. ) WAS OBSERVED IN THE DEVICE EVENT LOG. 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. THERE WERE NO REPAIRS AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180630 ↗
• MalfunctionJan 26, 2026Electrical /Electronic Property Problem; Pressure Problem

  THE BIPAP A30 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR THE REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, ALTHOUGH THERE WAS NO EVIDENCE OF FOAM DEGRADATION IN THE DEVICE A CRITICAL ERROR CODE IN RELATION TO (UNIT IS EXCEEDING THE REQUESTED PRESSURE SETTINGS FOR 10 SECONDS. ¿ HIGH PRESSURE SENSOR READING ¿ LARGE AMOUNT OF DRIFT ¿ PINCHED/BLOCKED TUBING SECONDS. ) WAS OBSERVED IN THE DEVICE EVENT LOG. THERE WERE NO REPAIRS TO THE UNIT AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179481 ↗
• MalfunctionJan 22, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  A BIPAP A30 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. 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 THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODES INDICATING (CPU CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS) 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 24151489 ↗
• MalfunctionDec 26, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DISCOVERY OF VENTILATOR INOPERATIVE ERROR CODES DURING EVALUATION. 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. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE WAS NOT IN PATIENT USE. DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER THE A30, FLOW GEN, BRAZIL DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION, HOWEVER A VENTILATOR INOPERATIVE ERROR CODE WAS CONFIRMED IN THE EVENT LOG. THERE IS NO DOCUMENTATION OF WHAT COMPONENT IS NECESSARY TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. SCRAPPING DEVICE DUE TO REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897003 ↗
• MalfunctionNov 5, 2025Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  THE TRILOGY BIPAP A30, FLOW GEN DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR FIELD ACTION: C&R 2021 05/06. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THERE WAS NO EVIDENCE OF FOAM DEGRADATION IN THE DEVICE. THE TECHNICIAN OBSERVED A VENTILATOR INOPERATIVE ERROR CODE IN RELATION TO (THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5). THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. THERE WAS NO FURTHER INVESTIGATION INTO THE CAUSE OF THE ERROR CODE DUE TO THE DEVICE WAS SCRAPPED. 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 23474187 ↗
• MalfunctionNov 4, 2025Electrical /Electronic Property Problem; Mechanical Problem; Increase in Pressure; Electrical /Electronic Property Problem; Mechanical Problem; Increase in Pressure

  THE TRILOGY A30, FLOW GEN DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR FIELD ACTION: C&R 2021 05/06. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THERE WAS NO EVIDENCE OF FOAM DEGRADATION IN THE DEVICE. THE TECHNICIAN CONFIRMED AN ERROR CODE IN RELATION TO (PT_HIGH_PRESS_CRITICAL_ALARM VENT_INOP) WAS RECORDED IN THE EVENT LOG. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. THE FINDING WILL NOT BE FURTHER INVESTIGATED DUE TO THE DEVICE WILL BE SCRAPPED. 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 23469359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113053. One submission often covers many models, so check the product and lot details in each record.

• Z-2036-2025 · May 9, 2025 · Open, Classified
  BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide n
• Z-1958-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
• Z-1957-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
• Z-1973-2021 · Jun 14, 2021 · Open, Classified
  DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respiron