Aeris Evo Aeris Evo VentilatorRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00606959062962), received between Jun 21, 2023 and Sep 24, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (29 reports).

4 FDA recall records name this device's identifier, 4 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. Oct 7, 2024Open, Classified

   Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

   Z-0294-2025 · Root cause: Device Design · FDA record ↗

2. Jul 16, 2024Open, Classified

   Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

   Z-2944-2024 · Root cause: Device Design · FDA record ↗

3. Mar 19, 2024Open, Classified

   Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

   Z-1499-2024 · Root cause: Device Design · FDA record ↗

4. May 1, 2023Open, Classified

   Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

   Z-1649-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889315 ↗
• MalfunctionJul 1, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, VENTILATOR SERVICE REQUIRED ALARMS E-384 AND E-386 INDICATING THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE MACHINE FLOW SENSOR REQUIRED REPLACEMENT TO ADDRESS THE ISSUE. THE DEVICE THEN PASSED FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676698 ↗
• MalfunctionApr 16, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MAINTENANCE REQUIRED HAD OCCURRED ON A AERIS EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE AERIS EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, MACHINE FLOW DRIFT HIGH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE MACHINE FLOW SENSOR HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS TWO NON-REPORTABLE ERROR CODES, DRIFT DEBUG AND OUT PRESSURE RAILED LOW, THAT WERE OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS ANOTHER ERROR CODE, MACHINE FLOW DRIFT LOG, THAT WAS OBSERVED IN THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE AIR INLET FOAM FILTER, PARTICULATE FILTER, AND MUFFLER ASSEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903997 ↗
• MalfunctionFeb 27, 2026Contamination; Pressure Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MAINTENANCE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO PRESSURE WAS OBSERVED. EVT_PRESS_SENSOR_MISMATCH MEANS THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE IN-PROCESS DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR CODE, BUT THE MACHINE FLOW SENSOR (PART# 1135249) HAS BEEN ARRANGED TO BE REPLACED DUE TO BEING CONTAMINATED WITH DUST. ADDITIONALLY, DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, OTHER NON-REPORTABLE ERROR CODES WERE OBSERVED. EVT_VOLTAGE_INT_LI MEANS THE INTERNAL LI-ION BATTERY EXCEEDED THE ACCEPTABLE THRESHOLD FOR A PERIOD OF TIME. THE SYSTEM BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. ALSO, EVT_VOLUME_UNDER_DELIVERY IS A TECHNICAL ALARM ACTIVE IN THE VOLUME MODES WHEN THE VENTILATOR CANNOT ACHIEVE DESIRED SETPOINT +/-15% DUE TO THE SYSTEM LIMITATIONS (E.G CURRENT LIMIT, MAXIMUM PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474733 ↗
• MalfunctionFeb 12, 2026No Device Output

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN AERIS EVO VENTILATOR NOT OPERATIVE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE AERIS EVO DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324410 ↗
• MalfunctionJan 12, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR NOT OPERATIONAL. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039366 ↗
• MalfunctionDec 15, 2025Contamination; Device Sensing Problem; Contamination; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION SERVICE REQUIRED ERROR CODE WAS FOUND ON A AERIS EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE AERIS EVO DEVICE WAS BEING EVALUATED BY THE THIRD-PARTY SERVICE CENTER WHEN THE ERROR CODE WAS FOUND ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE ERROR CODE, PRESSURE SENSOR MISMATCH (E-0384), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED THE DEVICE FURTHER TO FIND CONTAMINATION ON THE MACHINE FLOW SENSOR, BLOWER, AND IN-LINE PROXIMAL FILTER THAT HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR, BLOWER ASSEMBLY, AND IN-LINE PROXIMAL FILTER WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR INLET FOAM FILTER, PARTICULATE FILTER, AND MUFFLER ASSEMBLY WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803957 ↗
• MalfunctionDec 15, 2025Circuit Failure; Mechanical Problem; Failure to Calibrate; Circuit Failure; Mechanical Problem; Failure to Calibrate

  THE AERIS EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE AN ERROR CODE INDICATING (AEV_FAILURE) WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION, THE DEVICE'S TRILOGY EVO 3 WAY SOLENOID VALVE AND PROPORTIONAL VALVE (AECM) NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, AN ERROR CODE IN RELATION TO OUTLET PRESSURE SENSOR RAILED TO MAXIMUM NEGATIVE VALUE WAS RECORDED IN THE EVENT LOG UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE TECHNICIAN RECOMMENDS REPLACING THE SYSTEM BOARD TO ADDRESS THE ISSUE. THE INLET FOAM FILTER MUFFLER AND PARTICULATE FILTER WAS REPLACED AS A PART OF REQUIRED PREVENTATIVE MAINTENANCE. THE INTERNAL BATTERY DOOR IS DAMAGED AND NEEDS TO BE REPLACED. THE BLOWER, BLOWER CHASSIS PLATE, BELLOW, MACHINE FLOW SENSOR, PROXIMAL FILTERS, IN-LINE FILTER AND SYSTEM BOARD TUBING NEED TO BE REPLACED DUE TO CONTAMINATION. THE EVALUATION IS CURRENTLY IN PROCESS, AND REPAIRS HAVE NOT YET BEGUN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801101 ↗
• MalfunctionDec 5, 2025Contamination; Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem; Contamination; Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE INITIAL EVALUATION OF THE DEVICE A SERVICE REQUIRED ALARM INDICATING A PRESSURE SENSOR MISMATCH WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE EVALUATION HAS NOT YET BEEN COMPLETED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ANY ADDITIONAL INFORMATION IS RECEIVED ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727763 ↗
• MalfunctionDec 5, 2025Power Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT AN AERIS EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR COMPLETION OF REQUIRED MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. DEVICE EVALUATION REVEALED A VENTILATOR SERVICE REQUIRED ERROR CODE IN THE DOWNLOAD ERROR LOG INDICATING THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THAN OR EQUAL TO 1 MINUTE. EVALUATION DETERMINED THE DEVICE'S POWER SUPPLY REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. PREVENTATIVE MAINTENANCE WAS COMPLETED. THE DEVICE PASSED FINAL TESTING AFTER REPAIR AND WAS DETERMINED TO OPERATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726013 ↗
• MalfunctionDec 4, 2025Contamination; Decrease in Pressure; Contamination; Decrease in Pressure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE INSPIRATORY PHASE IS NOT WORKING ON A AERIS EVO. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE AERIS EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE INDICTING THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS WAS RECORDED IN THE DEVICE EVENT LOG CAUSED BY CONTAMINATION IN THE BLOWER, MACHINE FLOW SENSOR AND IN-LINE FILTER AND PROXIMAL FILTER. ADDITIONALLY, DUE TO PREVENTIVE MAINTENANCE, THE MUFFLER ASSEMBLY, PARTICULATE FILTER, AIR INLET FOAM FILTER NEED TO BE REPLACED, UNRELATED TO THE REPORTABLE MALFUNCTION. THE EVALUATION OF THE DEVICE IS STILL IN PROCESS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716622 ↗
• MalfunctionDec 2, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT THE TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION OF THE ALLEGATION THE LEFT FAN BEING BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR INJURY REPORTED. THE DEVICE ERROR LOG CONTAINED CRITICAL VENTILATOR INOPERATIVE ERROR CODES E-155 AND E-156 INDICATING THE MACHINE FLOW SENSOR COMMUNICATION CEASED AND THE SENSOR WAS STUCK AT THE SAME VALUE AND THE THERAPY CENTRAL PROCESSING UNIT WAS STILL RUNNING BOOT MONITOR SOFTWARE, RESPECTIVELY. EVALUATION COMPLETED BY THE THIRD-PARTY SERVICE PROVIDER INDICATED ALL ERRORS WERE CAUSED BY THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY (PCA) AND THE MACHINE FLOW SENSOR THAT HAD BEEN REPLACED IN THE DEVICE DURING THE LAST PREVENTATIVE MAINTENANCE. BOTH COMPONENTS WERE REPLACED AS PART OF SERVICE AND REPAIR. DEVICE EVALUATION ALSO REPORTED THE INLET SIDE PANEL AND COOLING FAN ASSEMBLY WERE DAMAGED AND REQUIRED REPLACEMENT. THE AIR INLET FOAM FILTER REQUIRED REPLACEMENT DUE TO PREVENTIVE MAINTENANCE. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696844 ↗
• MalfunctionNov 21, 2025Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION OF THE REPORTED MAINTENANCE REQUESTED ALARM THAT OCCURRED AFTER A SOFTWARE UPDATE. THERE NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, ERROR CODES E-200 AND E-201 INDICATE THERAPY BUZZER FAILURE AND POWER BUZZER FAILURE, RESPECTIVELY. THE BUZZER REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. AS PART OF PREVENTATIVE MAINTENANCE, THE AIR FOAM INLET FILTER REQUIRES REPLACEMENT. THE DEVICE PASSED ALL TESTING. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615603 ↗
• MalfunctionSep 5, 2025Device Sensing Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A AERIS EVO FAN WAS NOT WORKING. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE AERIS EVO WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER AND THE CUSTOMERS COMPLAINT WAS NOT CONFIRMED. THE DEVICE EVALUATION FOUND ERROR CODES RECORDED IN THE EVENT LOG INDICATING A VENTILATOR INOPERATIVE CONDITION OCCURRED., THEREFORE THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, ERROR CODES UNRELATED TO THE REPORTABLE MALFUNCTION WERE NOTED IN THE EVENT LOG THEREFORE, THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUES. THE MUFFLER ASSY AND IN-LINE FILTER PROX ARE CONTAMINATED THEREFORE WAS REPLACED. THE AIR INLET FOAM FILTER WAS REPLACED DUE TO PREVENTIVE MAINTENANCE. THE DEVICE PASSED ALL TEST. 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 22976069 ↗
• MalfunctionAug 20, 2025Contamination; Electrical /Electronic Property Problem; Contamination; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN AERIS EVO "FAN NOT WORKING" OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR WAS DISCOVERED IN THE AERIS EVO'S EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S MACHINE FLOW SENSOR TO ADDRESS THE ISSUE OF THE ERROR CODE AND CONTAMINATION. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DISPLAY BOARD NEEDS REPLACED DUE TO AN AMBIENT LIGHT SENSOR VERIFICATION: LUMINANCE TEST FAIL. THE INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE. MUFFLER ASSEMBLY IS CONTAMINATED. AFTER THE REPAIR, THE DEVICE PASSED ALL FUNCTIONAL TESTING AND QUALITY INSPECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849801 ↗
• MalfunctionAug 11, 2025Circuit Failure; Incorrect, Inadequate or Imprecise Result or Readings; Circuit Failure; Incorrect, Inadequate or Imprecise Result or Readings

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A AERIS EVO VENTILATOR (PROBLEM WITH THE HOUR METER IT INCORRECTLY DISPLAYS 14,000 HOURS) CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO HARM OR INJURY REPORTED. 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 22771591 ↗
• MalfunctionAug 11, 2025Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A AERIS EVO VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO HARM OR INJURY REPORTED. 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 22771379 ↗
• MalfunctionJul 1, 2025Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A AERIS EVO VENTILATOR "PRE ALERT" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, ERROR CODE E-133 (ACTIVE EXHALATION VALVE FAILURE) WAS RECORDED IN THE EVENT LOG, AND CONFIRMED BY THE TECHNICIAN THAT THE PROPORTIONAL VALVE AND 3 WAY SOLENOID VALVE (ON BLOWER CHASSIS) WERE DEFECTIVE AND NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. IN ADDITION, ERROR CODES E-208 AND E-330 WERE RECORDED INDICATING THE SYSTEM PCA NEEDS TO BE REPLACED. THE BLOWER ASSEMBLY AND MACHINE FLOW SENSOR ARE CONTAMINATED; VANITY COVER AND INTERNAL BATTERY DOOR ARE DAMAGED. DUE TO THE 4-YEAR PREVENTIVE MAINTENANCE, THE MUFFLER ASSEMBLY, PARTICULATE FILTER AND AIR INLET FOAM FILTER NEED TO BE REPLACED. THE UNIT WAS NOT SERVICED DUE TO THE CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369285 ↗
• MalfunctionMay 12, 2025Charging Problem; Charging Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER DUE TO AN ALLEGATION OF "SERVICE REQUIRED" AFTER SOFTWARE UPDATE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR INDICATING AN INTERNAL BATTERY NOT CHARGING FAULT WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S SYSTEM BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE'S AIR INLET FOAM FILTER WAS REPLACED DUE TO PREVENTIVE MAINTENANCE. THE DEVICE WAS REPAIRED AND PASSED ALL FINAL TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006389 ↗
• MalfunctionMay 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PRESSURE SENSOR MISMATCH ERROR CODE OCCURRED AFTER UPDATING AN AERIS EVO/TRILOGY EVO VENTILATOR FIRMWARE 1.6.10.00. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. IT IS NOTED THAT THIS WAS AN OUT OF BOX FAILURE AND THAT SOMETIMES AFTER A FEW HOURS OF RUN-IN, THE ERROR CLEARS, AND THEN SOMETIMES IT REMAINS. THE INTERNAL MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO RESTORE THE AERIS EVO/TRILOGY EVO DEVICE TO WORKING ORDER PER THE RECOMMENDATION OF VITALAIRE ITALY, MEDICAL EQUIPMENT PROVIDER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND THEREFORE, UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. AT THIS TIME A FINAL REPORT WILL BE SUBMITTED STATING THE RECOMMENDED RESOLUTION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964963 ↗
• MalfunctionMay 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PRESSURE SENSOR MISMATCH ERROR CODE OCCURRED AFTER UPDATING AN AERIS EVO/TRILOGY EVO VENTILATOR FIRMWARE 1.6.10.00. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. IT IS NOTED THAT THIS WAS AN OUT OF BOX FAILURE AND THAT SOMETIMES AFTER A FEW HOURS OF RUN-IN, THE ERROR CLEARS, AND THEN SOMETIMES IT REMAINS. THE INTERNAL MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO RESTORE THE AERIS EVO/TRILOGY EVO DEVICE TO WORKING ORDER PER THE RECOMMENDATION OF VITALAIRE ITALY, MEDICAL EQUIPMENT PROVIDER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND THEREFORE, UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. AT THIS TIME A FINAL REPORT WILL BE SUBMITTED STATING THE RECOMMENDED RESOLUTION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964960 ↗
• MalfunctionMay 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PRESSURE SENSOR MISMATCH ERROR CODE OCCURRED AFTER UPDATING AN AERIS EVO/TRILOGY EVO VENTILATOR FIRMWARE 1.6.10.00. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. IT IS NOTED THAT THIS WAS AN OUT OF BOX FAILURE AND THAT SOMETIMES AFTER A FEW HOURS OF RUN-IN, THE ERROR CLEARS, AND THEN SOMETIMES IT REMAINS. THE INTERNAL MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO RESTORE THE AERIS EVO/TRILOGY EVO DEVICE TO WORKING ORDER PER THE RECOMMENDATION OF VITALAIRE ITALY, MEDICAL EQUIPMENT PROVIDER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND THEREFORE, UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. AT THIS TIME A FINAL REPORT WILL BE SUBMITTED STATING THE RECOMMENDED RESOLUTION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964874 ↗
• MalfunctionApr 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED ALARM CONDITION, INDICATING A SENSOR MISMATCH ERROR WAS OBSERVED AFTER THE DEVICE'S FIRMWARE WAS UPGRADED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892542 ↗
• MalfunctionApr 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED ALARM CONDITION, INDICATING A SENSOR MISMATCH ERROR WAS OBSERVED AFTER THE DEVICE'S FIRMWARE WAS UPGRADED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891856 ↗
• MalfunctionMar 3, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR DID NOT PASS SERVICE TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE EVALUATION IS ONGOING. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510034 ↗