BiPAP A40 FRX3100S14Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00606959055100), received between May 28, 2023 and Sep 30, 2026 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (36 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 9, 2025Open, Classified

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

   Z-2037-2025 · Root cause: Device Design · FDA record ↗

2. Mar 26, 2024Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BiPAP A40 Pro device was returned to a third-party service center for evaluation. During evaluation of the device, a ¿ventilator inoperative¿ condition/error code 86 related to failure of the outlet pressure sensor was identified. There was no reported harm or injury.During further evaluation at the third-party service center, the recommended repair was replacement of the PCA board. However, the customer requested that the device be scrapped, and the device was not repaired.The evaluation of the device data also identified error codes unrelated to the reportable malfunction. 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.Due to a high internal O2 error E-228, PCA is faulty. E-228 is applicable for FCO00000002. This issue has been identified under the FSN 2023-CC-SRC-042. No errors applicable for FCO00000001. Device will be scrapped as per customer request. Based on the available information, there is not enough evidence to indicate this issue is reportable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951675 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a ventilator inoperative error code was found on a BiPAP 40 Pro 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, the power fail voltage is outside its valid range of 4.775 to 5.675 for at least ten seconds, in the device's error log. The third-party service technician further evaluated but was not able to determine the cause of the issue for this device. The root cause is not 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.Additionally, during the service of the device, the system printed circuit assembly needs replaced for another error code, error high internal O2, that was observed on the device's error log. This was unrelated to the reportable malfunction/issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937488 ↗
• MalfunctionSep 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935332 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934587 ↗
• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  The manufacturer received information alleging that a ventilator inoperative error code was identified in the event log of a BiPAP A40 Pro device in France during evaluation. This issue has been identified under FSN 2023-CC-SRC-039 due to interruptions and/or loss of therapy associated with a Ventilation Inoperative Alarm. No patient harm or serious injury was reported in association with this notification. During evaluation of the BiPAP A40 Pro device at a third-party service center, a ventilator inoperative error was confirmed in the event log. The error indicates that the difference between the blower pressure sensor reading and the outlet pressure sensor reading was 10 cmH2O or greater for 5 seconds. The technician identified a faulty Printed Circuit Assembly (PCA) as the root cause of the error. No repair was performed. The device will be scrapped at the customer's request. Device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881918 ↗
• MalfunctionSep 24, 2026Circuit Failure

  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 the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds. The service technician states that the printed circuit assembly (PCA) board needs to be replaced to resolve the error. No repairs were performed. The device will be scrapped per the customer's request.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881789 ↗
• MalfunctionJul 1, 2026Circuit Failure; Electrical /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, E20, 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 DEVICE AT A THIRD-PARTY SERVICE CENTER, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E20, INDICATING A DEFECTIVE EEPROM. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA) TO ADDRESS 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 PERFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682943 ↗
• MalfunctionJun 30, 2026Circuit Failure

  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 A DEFECTIVE EEPROM. THE SERVICE TECHNICIAN STATES THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD NEEDS TO BE REPLACED TO RESOLVE THE ERROR. ADDITIONALLY, THE DEVICE WAS VISUALLY INSPECTED, AND NO FOAM PARTICLES WERE OBSERVED. A NOT-REPORTABLE PROGRAM EXECUTION ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE PCA NEEDS TO BE REPLACED TO RESOLVE THIS ERROR AS WELL. NO REPAIRS WERE PERFORMED. THE DEVICE WILL BE SCRAPPED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666471 ↗
• MalfunctionJun 28, 2026Circuit Failure; Electrical /Electronic Property Problem

  A BIPAP A40 PROD EVICE 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-50 INDICATING 'THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS.' THE SERVICE TECHNICIAN NOTED THAT THE PCA IS DEFECTIVE AS A RESULT OF THIS ERROR CODE. 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 25648070 ↗
• MalfunctionJun 21, 2026Circuit Failure; Electrical /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-20, INDICATING 'DEFECTIVE EEPROM.' THE SERVICE TECHNICIAN NOTED THAT THE ERROR CODE IS A RESULT OF A FAULTY 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 IDENTIFIED TWO UNREPORTABLE ERROR CODES E-10 AND E-228, RECOMMENDING THE REPLACEMENT OF THE PCA. NO REPAIR WAS PERFORMED. THE DEVICE WAS SCRAPPED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572703 ↗
• MalfunctionJun 11, 2026Circuit Failure; Electrical /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 THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED A VENTILATOR INOPERATIVE ERROR CODE E020 (ERR_NVDATA_READBACK_FAILURE). THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS FOUND DEFECTIVE AND WILL NEED TO BE REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, THE DATA IDENTIFIED ADDITIONAL 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 25474318 ↗
• MalfunctionJun 5, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT 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 IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED. A ¿VENTILATOR INOPERATIVE¿ ERROR WAS OBSERVED, WHICH WAS ATTRIBUTED TO THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING BEING 10 CMH2O OR GREATER FOR 5 SECONDS. FURTHER ASSESSMENT DETERMINED THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) REQUIRED REPLACEMENT. A HIGH INTERNAL OXYGEN ALARM WAS ALSO OBSERVED, AND PCA REPLACEMENT WAS DETERMINED TO BE NECESSARY TO ADDRESS THIS CONDITION. ADDITIONALLY, DUST CONTAMINATION WAS OBSERVED WITHIN THE DEVICE. THE DEVICE WILL BE 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 25409738 ↗
• MalfunctionJun 5, 2026Circuit Failure

  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 BIPAP A40 PRO AT A THIRD-PARTY SERVICE CENTER, THE EVENT LOG WAS REVIEWED AND THERE WAS A VENTILATOR INOPERATIVE ERROR CODE, E-20, INDICATING "DEFECTIVE EEPROM." NO REPAIRS WERE PERFORMED. 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 25403560 ↗
• MalfunctionJun 3, 2026Circuit Failure; Electrical /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. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S PCA TO ADDRESS 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 THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383999 ↗
• MalfunctionJun 1, 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 THE DIFFERENCE BETWEEN THE BLOWER PRESSURE SENSOR READING AND THE OUTLET PRESSURE SENSOR READING IS 10 CMH2O OR GREATER FOR 5 SECONDS. NO REPAIRS WERE PERFORMED. THE DEVICE WILL BE SCRAPPED PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354676 ↗
• MalfunctionOct 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "FAN" INOPERATIVE ALARM HAD OCCURRED ON A BIPAP A40 PRO DEVICE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285637 ↗
• MalfunctionJul 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO A VENTILATOR INOPERATIVE CONDITION OCCURRING IN CERTAIN BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION ON THE DEVICE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (FRX3100S14) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394753 ↗
• MalfunctionJun 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED WHILE IN PATIENT USE. 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 HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353085 ↗
• MalfunctionJun 26, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335134 ↗
• MalfunctionApr 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION ON 08 APRIL 2025. HOWEVER, DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919463 ↗
• MalfunctionJan 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO (FRX3100S14) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207866 ↗
• MalfunctionNov 29, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR TURNS OFF. 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 20810348 ↗
• MalfunctionNov 29, 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. 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 20810203 ↗
• MalfunctionNov 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. 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 20797132 ↗
• MalfunctionNov 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. 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 20796698 ↗