BiPAP A30 BiPAP A30 Silver Series Ventilator, DERecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00606959039384), received between Mar 25, 2022 and Mar 13, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 9, 2025Class IOpen, Classified

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

   Z-2036-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 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 PATIENT¿S COMPLAINT WAS CONFIRMED ALONG WITH CONTAMINATION, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597798 ↗
• MalfunctionMar 10, 2026Overheating of Device

  A BIPAP A30 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND BURNT CONNECTOR WAS OBSERVED. ADDITIONALLY, THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561006 ↗
• MalfunctionMar 6, 2026Overheating of Device

  A BIPAP A30 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE AND BURNT CONNECTOR. ADDITIONALLY, THE PATIENT'S COMPLAINT WAS NOT CONFIRMED AND THE DEVICE WAS CORRECTED. AT THIS TIME, THE DEVICE WAS SENT FOR FURTHER INVESTIGATION TO PRODUCT INVESTIGATION LABORATORY (PIL). IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539574 ↗
• MalfunctionMar 5, 2026Computer Software Problem; Degraded; Electrical /Electronic Property Problem

  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, ERROR CODE RELATED TO VENTILATOR INOPERATIVE CONDITION WAS FOUND. ALSO, FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, NOT RELATED TO THE ISSUE, THERE IS DUST/DIRT AND TOBACCO CONTAMINATION PRESENT INSIDE THE DEVICE. THE UNIT WORKS IN NORMAL PARAMETERS; THE SOFTWARE WAS UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516872 ↗
• MalfunctionMar 3, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE DEVICE WORKS IN PARAMETERS. THE SOFTWARE WAS UPGRADED WITH THE LATEST VERSION, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501443 ↗
• 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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE DEVICE WORKS IN PARAMETERS. THE SOFTWARE WAS UPGRADED WITH THE LATEST VERSION, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501278 ↗
• MalfunctionMar 3, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  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. DURING EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493568 ↗
• MalfunctionFeb 26, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455533 ↗
• MalfunctionFeb 26, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  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 EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455522 ↗
• MalfunctionSep 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  A BIPAP A30, SILVER SERIES DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THERE WAS NO INJURY OR HARM REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT 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. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. ADDITIONALLY, A CRITICAL ERROR CODE E-47 AND E-96 WAS NOTED TO HAVE OCCURRED INDICATING THE CENTRAL PROCESSING UNIT CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS. REPLACEMENT OF THE DEVICE'S SYSTEM BOARD WAS REQUIRED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL FINAL TESTING. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939576 ↗
• MalfunctionNov 26, 2024Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE AND CANNOT POWER CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785301 ↗
• MalfunctionOct 9, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THIS MALFUNCTION IS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH (B)(4). UPON REVIEW, THIS MALFUNCTION HAS BEEN DEEMED A REPORTABLE MALFUNCTION. THIS MALFUNCTION IF IT WERE TO RECUR COULD RESULT IN PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406591 ↗
• MalfunctionSep 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20321330 ↗
• MalfunctionSep 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20310511 ↗
• MalfunctionSep 26, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20309094 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305172 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305014 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304969 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304962 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304873 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304871 ↗
• MalfunctionSep 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304784 ↗
• MalfunctionSep 25, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20299940 ↗
• MalfunctionSep 24, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20291037 ↗
• MalfunctionSep 23, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. UPON FURTHER REVIEW, THIS COMPLAINT HAS BEEN DEEMED AS A REPORTABLE EVENT. 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 20286715 ↗

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-1654-2022 · Aug 26, 2022 · Open, Classified
  Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
• 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 Respironic
• 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-1958-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting