BiPAP A40 GBX3100S19Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00606959055063), received between Oct 30, 2023 and Jun 30, 2026 — classified as 1 death, 1 injury, 155 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (127 reports).

2 FDA recall records name this device's identifier, 2 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. 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-2037-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 26, 2024Class IOpen, Classified

   Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

   Z-1813-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED FROM THE DEVICE DATA THAT THERE IS A FAILURE OF THE OUTLET PRESSURE SENSOR (ERROR CODE 86). ERROR CODE 86 IS A VENTILATOR INOPERATIVE CODE. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. 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 DEVICE WAS RENDERED INOPERABLE AND DISPOSED OF BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665140 ↗
• MalfunctionJun 29, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PROEFL VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. DEVICE EVALUATION BY THE THIRD-PARTY SERVICE CENTER INDICATED A VENTILATOR INOPERATIVE DEVICE ERROR CODE WAS PRESENT IN THE ERROR LOG INDICATING FAILURE OF THE OUTLET PRESSURE SENSOR. THE ISSUE WOULD REQUIRE REPLACEMENT OF THE DEVICE PRINTED CIRCUIT BOARD ASSEMBLY TO ADDRESS THE ISSUE. HOWEVER; NO PARTS WERE REPLACED. THE CUSTOMER REQUESTED THE DEVICE BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25657554 ↗
• MalfunctionJun 17, 2026Electrical /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, AN ERROR CODE RELATED TO VENTILATOR INOPERATIVE CONDITION WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE HAD BEEN RENDERED INOPERABLE AND DISPOSED OF. 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 25530048 ↗
• MalfunctionJun 15, 2026Electrical /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, AN ERROR CODE RELATED TO VENTILATOR INOPERATIVE CONDITION WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE HAD BEEN RENDERED INOPERABLE AND DISPOSED OF. 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 25504449 ↗
• MalfunctionJun 12, 2026Electrical /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 CONDITION OCCURRED. THE DEVICE HAD BEEN RENDERED INOPERABLE AND DISPOSED OF. 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 25491910 ↗
• MalfunctionJun 9, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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. TWO VENTILATOR INOPERATIVE ERROR CODES WERE IDENTIFIED, INDICATING, CPU CANNOT COMMUNICATE WITH THE FLOW SENSOR USING I2C BUS AND CPU CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SPI BUS. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE ISSUE. THE DEVICE WAS RENDERED INOPERABLE AND DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439387 ↗
• MalfunctionJun 5, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING EVALUATION OF THE DEVICE, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E50, IN THE DEVICE'S HISTORY. 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 BIPAP A40 PRO AT A THIRD-PARTY SERVICE CENTER, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E50, INDICATING THAT THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS. THERE WAS NO CAUSE NOTED BY THE SERVICE TECHNICIAN THAT CONTRIBUTED TO THE VENTILATOR INOPERATIVE ERROR CODE. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED AN UNRELATED ERROR CODE, E229, LINKED TO THE STATUS OF THE FAN OPERATION. THIS ERROR CODE IS NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25416391 ↗
• MalfunctionJun 5, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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 IDENTIFIED A VENTILATOR INOPERATIVE CODE E-45 (3 REBOOTS OCCURRED WITHIN 24 HOURS). THE AVAILABLE REPAIR EVALUATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. 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 25414229 ↗
• MalfunctionJun 1, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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 IDENTIFIED A VENTILATOR INOPERATIVE ERROR CODE E-86 (FAILURE OF THE OUTLET PRESSURE SENSOR). THE AVAILABLE REPAIR EVALUATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. 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 25356484 ↗
• MalfunctionMay 26, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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 FAILURE OF THE OUTLET PRESSURE SENSOR. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. THE DEVICE HAS BEEN RENDERED INOPERABLE AND DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279201 ↗
• MalfunctionMay 21, 2026Electrical /Electronic Property Problem

  A BIPAP A40 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 FAILURE OF THE OUTLET PRESSURE SENSOR. THE DEVICE HAS BEEN RENDERED INOPERABLE AND DISPOSED OF. NO REPAIRS WERE PERFORMED. THE DEVICE WILL BE SCRAPPED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242017 ↗
• MalfunctionMay 16, 2026Electrical /Electronic Property Problem

  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 IDENTIFIED A VENTILATOR INOPERATIVE CODE E-86 (FAILURE OF THE OUTLET PRESSURE SENSOR.) THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA); HOWEVER, THE AVAILABLE REPAIR EVALUATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED 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. 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 25196082 ↗
• MalfunctionMay 14, 2026Electrical /Electronic Property Problem

  A BIPAP A40 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. THE DEVICE HAS BEEN RENDERED INOPERABLE AND DISPOSED OF. NO REPAIRS WERE PERFORMED. THE DEVICE WILL BE SCRAPPED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173472 ↗
• MalfunctionMay 14, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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 IDENTIFIED A VENTILATOR INOPERATIVE ERROR CODE E-86 (FAILURE OF THE OUTLET PRESSURE SENSOR). THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA); HOWEVER, THE AVAILABLE REPAIR EVALUATION DID NOT SPECIFY WHICH COMPONENT REPLACEMENT WOULD BE REQUIRED TO RESOLVE THE ISSUE. 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 25167513 ↗
• MalfunctionMay 11, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS (ERROR CODE 50). ERROR CODE 50 IS A VENTILATOR INOPERATIVE CODE. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. AFTER THE EVALUATION WAS COMPLETE, THE DEVICE WAS RENDERED INOPERABLE AND DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142762 ↗
• MalfunctionMay 11, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE ERROR CODE WAS FOUND ON A BIPAP A40 PRO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, PIC PROCESSOR OR ASSOCIATED CIRCUITRY FAILURE, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THERE WAS NO DOCUMENTATION BY THE THIRD-PARTY SERVICE TECHNICIAN THAT STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE PIC PROCESSOR OR ASSOCIATED CIRCUITRY FAILURE ERROR CODE. 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. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, TWO ADDITIONAL, ERROR CODES, HIGH INTERNAL O2 HIGH ALARM AND FAN STATUS, WERE OBSERVED ON THE DEVICE'S ERROR LOG. THERE WAS NO DOCUMENTATION BY THE THIRD-PARTY SERVICE TECHNICIAN THAT STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE HIGH INTERNAL O2 HIGH ALARM AND FAN STATUS ERROR CODES. THESE TWO ERROR COD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140991 ↗
• MalfunctionMay 11, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE ERROR CODE WAS FOUND ON A BIPAP A40 PRO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, DEFECTIVE DEFECTIVE ELECTRICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY., WAS OBSERVED ON THE DEVICE'S ERROR LOG. THERE WAS NO DOCUMENTATION BY THE THIRD-PARTY SERVICE TECHNICIAN THAT STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE FAILURE OF THE OUTLET PRESSURE SENSOR ERROR CODE. 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. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, TWO ADDITIONAL, ERROR CODES, HIGH INTERNAL O2 HIGH ALARM AND FAN STATUS, WERE OBSERVED ON THE DEVICE'S ERROR LOG. THERE WAS NO DOCUMENTATION BY THE THIRD-PARTY SERVICE TECHNICIAN THAT STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE HIGH INTERNAL O2 HIGH ALARM AND FAN STATUS ERROR CODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137706 ↗
• MalfunctionMay 10, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE WAS CONFIRMED IN THE EVENT LOG PERTAINING TO THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. THE DEVICE WILL BE DISPOSED OF; 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 25133473 ↗
• MalfunctionMay 8, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. MULTIPLE ¿VENTILATOR INOPERATIVE¿ ERRORS WERE IDENTIFIED, INDICATING THAT THE CENTRAL PROCESSING UNIT (CPU) COULD NOT COMMUNICATE WITH THE FLOW SENSOR USING I2C BUS AND WITH THE PRESSURE SENSOR USING SPI BUS. AN ADDITIONAL "VENTILATOR INOPERATIVE" ERROR WAS IDENTIFIED RELATED TO FAILURE OF THE OUTLET PRESSURE SENSOR. THE SERVICE MANUAL RECOMMENDS REPLACEMENT OF THE PRINTED CIRCUIT ASSEMBLY (PCA) TO ADDRESS THESE ISSUES; HOWEVER, NO DOCUMENTATION WAS PROVIDED CONFIRMING WHETHER ANY COMPONENTS WERE REPLACED. NO OTHER ACTIONABLE ERROR CODES WERE OBSERVED. ADDITIONALLY, UNRELATED TO THE REPORTED MALFUNCTION, A HIGH INTERNAL O2 ALARM ASSOCIATED WITH O2 SENSOR FAILURE WAS OBSERVED IN THE DEVICE LOGS. THE DEVICE HAD BEEN RENDERED INOPERABLE AND DISPOSED OF; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125186 ↗
• MalfunctionMay 8, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO UK DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WERE NO REPORTS OF HARM OR INJURY, AND THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE EVENT. DURING THE EVALUATION, THE SERVICE TECHNICIAN IDENTIFIED A VENTILATOR INOPERATIVE ERROR IN THE DEVICE'S EVENT LOG. THE ERROR WAS RELATED TO A CONDITION IN WHICH THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING REACHED 10 CMH2O OR GREATER FOR 5 SECONDS. THIS ISSUE IS ASSOCIATED WITH FSN 2023-CC-SRC-039, WHICH ADDRESSES POTENTIAL INTERRUPTIONS OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO DOCUMENTATION INDICATING WHICH COMPONENT WOULD BE REQUIRED TO CORRECT THE INOPERATIVE ERROR. THE DEVICE WAS RENDERED INOPERABLE AND DISPOSED OF IN ACCORDANCE WITH THE FIELD CORRECTIVE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124623 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  A BIPAP A 40 PRO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. 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, A VENTILATOR INOPERATIVE ERROR CODE WAS PRESENT IN THE DEVICE EVENT LOG IN RELATION TO PIC_FAILED. 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. THE DEVICE HAS BEEN RENDERED INOPERABLE AND HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119221 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  A BIPAP A 40 PRO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. 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, A VENTILATOR INOPERATIVE ERROR CODE WAS PRESENT IN THE DEVICE EVENT LOG IN RELATION TO THE NVDATA_READBACK_FAILURE. 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. THE DEVICE HAS BEEN RENDERED INOPERABLE AND HAS BEEN SCRAPPED. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, AN ERROR CODE IN RELATION TO HIGH INTERNAL O2 WAS RECORDED IN THE DEVICE EVENT LOG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113743 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PROEFL VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE NOTIFICATION RELATED TO A VENTILATOR INOPERATIVE CONDITION IN BIPAP MECHANICAL VENTILATOR DEVICES. THERE WAS NO HARM OR INJURY REPORTED. REVIEW OF THE DEVICE ERROR LOG INDICATE VENTILATOR INOPERATIVE ERROR CODE E-47 INDICATING THE CENTRAL PROCESSING UNIT (CPU) CANNOT COMMUNICATE WITH THE PRESSURE SENSOR USING SERIAL PERIPHERAL INTERFACE (SPI) BUS. THE DEVICE HAS BEEN RENDERED INOPERABLE AND DISPOSED OF WITHOUT REPAIR IN ACCORDANCE WITH PHILIPS FIELD CHANGE ORDER (B)(4). THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113572 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO 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 RELATING TO 'PRESSURE FAILED' WAS FOUND IN THE DEVICE'S ERROR LOG. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR A COMPONENT REPLACEMENT TO RESOLVE THE ISSUE. THE DEVICE HAS BEEN RENDERED INOPERABLE AND DISPOSED OF ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113449 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. 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 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 A VENTILATOR INOPERATIVE ERROR CODE E206 (PIC PROCESSOR OR ASSOCIATED CIRCUITRY FAILURE). THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE VENTILATOR INOPERATIVE CONDITION. THE DEVICE HAD BEEN RENDERED INOPERABLE AND DISPOSED OF; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112923 ↗