BiPAP A30 BiPAP A30 Ventilator, FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00606959039353), received between Mar 3, 2021 and Sep 29, 2026 — classified as 2 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Degraded” (29 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938447 ↗
• MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938439 ↗
• MalfunctionSep 15, 2026Electrical /Electronic Property Problem

  A Bipap A30 device was returned to a third-party service center for service. There was no serious patient harm or injury that occurred or was reported.During the evaluation at the third-party service center, a ventilator inoperative error code was found in the device's error log stating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. There is no documentation stated on a root cause and/or any component replacement to resolve the issue.No repairs were performed. The device will be scrapped per the customer's request.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775302 ↗
• MalfunctionSep 14, 2026Circuit Failure; Degraded; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762102 ↗
• MalfunctionSep 10, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713932 ↗
• MalfunctionAug 5, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145809 ↗
• MalfunctionAug 4, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133310 ↗
• MalfunctionMay 11, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THERE WERE TWO VENTILATOR INOPERATIVE ERROR CODES FOUND ON A BIPAP A30 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE THIRD-PARTY SERVICE TECHNICIAN OBSERVED THE ERROR CODE, CPU CANNOT COMMUNICATE WITH THE FLOW SENSOR USING I2C BUS AND CPU CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS, IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD HAD CAUSED THE ERROR CODES TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S PCA BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THE DEVICE WAS SCRAPPED PER THE CUSTOMER REQUEST. 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 25135299 ↗
• MalfunctionApr 1, 2026Degraded

  A BIPAP A30 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST/DIRT/TOBACCO CONTAMINATION AND MISSING RUBBER FEET. THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES, AND THE PRINTED CIRCUIT ASSEMBLY (PCA) WILL NEED TO BE REPLACED. THESE ERROR CODES WERE 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 THE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WILL BE SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758020 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property 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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. A ¿VENTILATOR INOPERATIVE¿ ERROR CODE WAS OBSERVED (E-20), INDICATING DEFECTIVE EEPROM. THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA); HOWEVER, THE AVAILABLE DOCUMENTATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. THE TECHNICIAN ALSO IDENTIFIED ERROR CODE E-96, INDICATING "UNABLE TO WRITE TO EVENT LOG." AS A RESULT OF E-96, THE TECHNICIAN RECOMMENDED REPLACING THE PCA. 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 DUST/DIRT AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732534 ↗
• MalfunctionMar 30, 2026Circuit Failure; Electrical /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 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 CODE INDICATING A FAILURE OF THE OUTLET PRESSURE SENSOR WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE. NO FINAL TESTING WAS DOCUMENTED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729908 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property 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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. A ¿VENTILATOR INOPERATIVE¿ ERROR WAS OBSERVED (E-20), INDICATING DEFECTIVE EEPROM. THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA); HOWEVER, THE AVAILABLE DOCUMENTATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. THE TECHNICIAN NOTED IN THE EVALUATION NOTES THAT THE UNIT IS WORKING IN PARAMETERS AND THE SOFTWARE WAS UPDATED. 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 DUST/DIRT AND TOBACCO CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729031 ↗
• MalfunctionMar 30, 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 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 CODE INDICATING A FAILURE OF THE OUTLET PRESSURE SENSOR WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THERE WAS NO DOCUMENTATION OF ANY COMPONENT BEING REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728847 ↗
• MalfunctionMar 25, 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. 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 BIPAP A30, THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. 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 DIRT/DUST AND TOBACCO CONTAMINATION PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687034 ↗
• MalfunctionMar 20, 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. 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 BIPAP A30, THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DIRT/DUST AND TOBACCO CONTAMINATION PRESENT, AND PCA NEEDS TO BE REPLACED. 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 24655975 ↗
• MalfunctionMar 20, 2026Degraded

  THE BIPAP A30 DEVICE WAS EVALUATED 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. 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 CONTAMINATION AND DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649702 ↗
• MalfunctionMar 20, 2026Degraded

  THE BIPAP A30 DEVICE WAS EVALUATED 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. 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 CONTAMINATION AND DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649657 ↗
• MalfunctionMar 17, 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. 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 BIPAP A30, THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. 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 DIRT/DUST AND TOBACCO CONTAMINATION PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621661 ↗
• MalfunctionMar 13, 2026Degraded

  THE DEVICE WAS EVALUATED 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 BIPAP A30, FRANCE, DEVICE AT A THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. NO VISUAL DEFECTS WERE FOUND. THE DEVICE IS MISSING RUBBER FEET. NO REPAIR WAS PERFORMED. THE DEVICE WILL BE SCRAPPED AS PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591095 ↗
• MalfunctionMar 13, 2026Degraded

  THE BIPAP A30 VENTILATOR WAS RETURNED TO THE 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 ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, EVIDENCE OF FOAM DEGRADATION INSIDE THE ASSEMBLY, DETERIORATED FOAM WAS PRESENT. ADDITIONALLY, DURING THE EVALUATION THE TECHNICIAN CONFIRMED DEAD PIXELS ON THE DISPLAY AND THE ACCESSORY PORT COVER WAS MISSING UNRELATED TO THE REPORTABLE MALFUNCTION. THERE WERE NO REPAIRS PERFORMED AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590566 ↗
• MalfunctionMar 10, 2026Degraded

  A BIPAP A30 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE ASSEMBLY. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST/DIRT/TOBACCO CONTAMINATION, AND THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES WERE 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 THE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WILL BE SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561676 ↗
• MalfunctionFeb 26, 2026Degraded

  A BIPAP A30 VENTILATOR 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 DUST/DIRT, 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 24465229 ↗
• MalfunctionFeb 16, 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. 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 BIPAP A30, THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. 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 DIRT/DUST AND TOBACCO CONTAMINATION PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24354739 ↗
• MalfunctionFeb 16, 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. 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 BIPAP A30, THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. 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 DIRT/DUST AND TOBACCO CONTAMINATION PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24354738 ↗
• MalfunctionFeb 13, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A BIPAP A30 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A VENTILATOR SERVICE REQUIRED ERROR WAS NOTED IN THE IN THE DEVICE ERROR LOG. THE ERROR CODE WAS IDENTIFIED AS A FAILURE OF THE OUTLET PRESSURE SENSOR, REQUIRING REPLACEMENT OF THE DEVICE PRINTED CIRCUIT BOARD ASSEMBLY TO ADDRESS THE ISSUE. NO REPAIRS WERE COMPLETED; THE DEVICE WAS PROCESSED AS SCRAP PER THE CUSTOMER'S REQUEST. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333329 ↗

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-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
• 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