LifeVent EVO2 SP2100X26BRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00606959057456), received between Oct 8, 2020 and Sep 24, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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-0296-2025 · 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-1501-2024 · Root cause: Device Design · FDA record ↗

4. Mar 1, 2023Open, Classified

   The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.

   Z-1287-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Mechanical Problem

  A LifeVent EVO2 ventilator was returned to a third-party service center following display of a ventilator service required message. There was no allegation of patient harm, and the device was not reported to have been in patient use.During preliminary ¿INPROCESS¿ evaluation at the third-party service center, the device event log was reviewed and identified error code 81-EVT_OBM_VALVE_FAILURE, indicating that the O2 proportional valve, which controls the flow of O2 to the blower inlet, was mechanically stuck closed or open. Error code 149-EVT_O2_FLOW_STUCK was also identified, indicating that O2 flow communication had ceased and the sensor was reporting the same value. The technician recommended replacement of the Oxygen Blender Module (OBM) to address both critical errors.Additionally, replacement of the OBM was expected to address the condition associated with the EVT_O2_PRESSURE_RAILED_LOW alarm, indicating that the O2 pressure sensor had railed to a maximum negative value. Other errors were also identified during the evaluation; however, they were reported as not requiring attention at this time.No repair had been completed at the time of this report because the customer's appro

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882032 ↗
• MalfunctionJun 17, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A LIFEVENT EVO2 VENTILATOR WAS RETURNED FOR PREVENTIVE MAINTENANCE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE SIGNIFICANT EVENT LOG TEST. THE DEVICE ERROR LOG WAS SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. MULTIPLE ERRORS WERE IDENTIFIED. A "VENT SERVICE REQUIRED" ERROR WAS RECORDED INDICATING THAT THE OXYGEN PROPORTIONAL VALVE, WHICH CONTROLS OXYGEN FLOW TO THE BLOWER INLET, WAS MECHANICALLY STUCK IN EITHER THE CLOSED OR OPEN POSITION. AN ADDITIONAL "VENT SERVICE REQUIRED" ERROR INDICATED THAT COMMUNICATION WITH THE OXYGEN FLOW SENSOR HAD CEASED AND THE SENSOR WAS REPORTING A CONSTANT VALUE. ANOTHER ERROR INDICATED THAT THE OXYGEN PRESSURE SENSOR HAD RAILED TO ITS MAXIMUM NEGATIVE VALUE. A "VENT INOP" ERROR WAS IDENTIFIED DUE TO FAILURES OF BOTH THE OUTLET PRESSURE SENSOR AND MONITOR PRESSURE SENSOR. ADDITIONAL "VENT SERVICE REQUIRED" ERRORS WERE IDENTIFIED INDICATING THAT THE OUTLET PRESSURE SENSOR AND MONITOR PRESSURE SENSOR HAD RAILED TO THEIR MAXIMUM POSITIVE VALUES. AN EVENT ERROR WAS ALSO IDENTIFIED INDICATING THAT THE 3.3V SUPPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25531136 ↗
• MalfunctionMay 29, 2026Circuit Failure; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A LIFEVENT EVO2 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR THE REPORT OF A CIRCUIT CALIBRATION ISSUE. THERE WAS HARM OR INJURY REPORTED. PREVENTATIVE MAINTENANCE WAS COMPLETED ON THE DEVICE AND COMPONENT REPLACEMENT(S) COMPLETED AS PER MAINTENANCE SCHEDULE. REVIEW OF THE DOWNLOADED DEVICE ERROR LOG INDICATED THE OCCURRENCE OF VENTILATOR SERVICE REQUIRED ALARM CODE E-384 INDICATING THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY (PCA) TUBING AND FIO2 TUBING, ALONG WITH THE OXYGEN BLENDING MODULE (OBM) NEED TO BE REPLACED (ASSOCIATED WITH THE VENTILATOR SERVICE REQUIRED ALARM) DUE TO DUST CONTAMINATION AND DEBRIS INSIDE THE TUBING. NO COMPONENTS WERE REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER UNREPAIRED AS PER THE CUSTOMER'S REQUEST. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: NON-CRITICAL DEVICE ERROR CODE E-330 WAS NOTED IN THE ERROR LOG INDICATING THE SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY WOULD REQUIRE REPLACEMENT TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330621 ↗
• MalfunctionMar 20, 2026Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER ALLEGING A LIFE VENT EVO2 VENTILATOR INOPERATIVE CONDITION OCCURRED WHILE IN PATIENT USE. THE CUSTOMER STATES THE ALARM IS TRIGGERED (VENTILATOR INOPERATIVE) WHEN THE PATIENT STOPS THERAPY DURING THE NIGHT TO GO TO THE BATHROOM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650959 ↗
• MalfunctionDec 4, 2025Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NECESSARY ASSISTANCE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, ERROR CODES RELATED TO O2 WERE OBSERVED. EVT_OBM_VALVE_FAILURE MEANS THE O2 PROPORTIONAL VALVE THAT CONTROLS THE FLOW OF O2 TO THE BLOWER INLET IS MECHANICALLY STUCK CLOSED OR OPEN. EVT_O2_FLOW_RAILED_LOW MEANS THE O2 FLOW SENSOR RAILED TO MAXIMUM NEGATIVE VALUE. EVT_O2_FLOW_STUCK MEANS THE O2 FLOW COMMUNICATION CEASED AND THE SENSOR IS REPORTING THE SAME VALUE. THE OXYGEN BLENDING MODULE NEEDS TO BE REPLACED TO ADDRESS THESE ISSUES. ADDITIONALLY, NON-REPORTABLE ERROR CODES WERE OBSERVED. EVT_O2_PRESSURE_RAILED_LOW MEANS THE O2 PRESSURE SENSOR RAILED TO MAXIMUM NEGATIVE VALUE. EVT_MODEL_NUM_OBM_MISMATCH MEANS A VENTILATOR THAT IS GIVEN A MODEL NUMBER TO HAVE AN OBM DOES NOT HAVE ONE INSTALLED WHEN IT SHOULD BE. THE OXYGEN BLENDING MODULE NEEDS TO BE REPLACED TO ADDRESS THESE ISSUES. EVT_OUT_PRESS_RAILED_LOW MEANS THE OUTLET PRESSURE SENSOR RAILED TO MAXIMUM NEGATIVE VALUE. EVT_MON_PRESS_RAILED_LOW MEANS THE MONITOR PRESSURE SENSOR RAILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716148 ↗
• MalfunctionDec 4, 2025Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING BREATHING ERROR DETECTED VISIBLE WITH PNEUMATIC TEST. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE ERROR LOG WAS CHECKED AND AN ERROR CODE RELATED TO THE OXYGEN BLENDING MODULE WAS FOUND. EVT_OBM_VALVE_FAILURE MEANS THE O2 PROPORTIONAL VALVE THAT CONTROLS THE FLOW OF O2 TO THE BLOWER INLET IS MECHANICALLY STUCK CLOSED OR OPEN. THE OXYGEN BLENDING MODULE HARNESS NEEDS REPLACED TO ADDRESS THE ISSUE. ALSO, AN ERROR CODE RELATED TO O2 FLOW WAS FOUND. EVT_O2_FLOW_STUCK MEANS O2 FLOW COMMUNICATION CEASED AND THE SENSOR IS REPORTING THE SAME VALUE. THE OXYGEN BLENDING MODULE SUBASSEMBLY NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ERROR CODES, AN ERROR CODE RELATED TO THE CALIBRATION DATA TABLE WAS FOUND. TWO ERROR CODES RELATED TO VOLTAGE WERE FOUND. EVT_VOLTAGE_3VS3_FAIL MEANS THE 3.3V SUPPLY RAIL EXCEEDED OR DROPPED BELOW THRESHOLD DUE TO COMPONENT TOLERANCE/DRIFT. EVT_VOLTAGE_5VS2_FAIL MEANS THE 5V SUPPLY RAIL EXCEEDED OR DROPPED BELOW THRESHOLD DUE TO COMPONENT TOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715459 ↗
• MalfunctionNov 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A TRILOGY EVO DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, THE MANUFACTUERE IS 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 23644909 ↗
• MalfunctionOct 16, 2025Power Problem; No Apparent Adverse Event; Power Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING "IT DOES NOT WORK" FOR A LIFEVENT EVO2 DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER, BUT EVALUATION HAS NOT YET BEGUN. 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 23316510 ↗
• MalfunctionOct 15, 2025Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING WATER INSIDE THE BLOWER. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE VENTILATOR WAS RETURNED TO THIRD-PARTY SERVICE CENTER FOR EVALUATION, ERROR CODES RELATED TO THE OXYGEN BLENDING MODULE, O2 AND THE DISPLAY WERE OBSERVED. EVT_OBM_VALVE_FAILURE MEANS THE O2 PROPORTIONAL VALVE THAT CONTROLS THE FLOW OF O2 TO THE BLOWER INLET IS MECHANICALLY STUCK CLOSED OR OPEN. EVT_O2_FLOW_STUCK MEANS THE O2 FLOW COMMUNICATION CEASED, AND THE SENSOR IS REPORTING THE SAME VALUE. EVT_O2_PRESSURE_RAILED_LOW MEANS THE O2 PRESSURE SENSOR RAILED TO MAXIMUM NEGATIVE VALUE. THE OXYGEN BLENDING MODULE SUB-ASSEMBLY WAS REPLACED TO ADDRESS THESE ISSUES. EVT_UI_BACKLIGHT_FAIL MEANS THE BACKLIGHT IS BLANK IN ANY STATE OTHER THAN ¿OFF¿. THERAPY WILL STILL BE PROVIDED BASED ON CURRENT SETTINGS BUT WILL NOT BE ABLE TO MODIFY THE SETTINGS. EVT_TOUCHSCREEN_FAIL MEANS THE TOUCH SCREEN IS UNRESPONSIVE. THERAPY WILL STILL BE PROVIDED BASED ON CURRENT SETTINGS BUT WILL NOT BE ABLE TO MODIFY THE SETTINGS. THE DISPLAY WAS REPLACED TO ADDRESS THESE ISSUES. ADDITIONALLY, DURING EVALUATION OF THE DEVICE AT THE THIRD-SERVICE CENTER, AN ERROR CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279656 ↗
• MalfunctionJul 11, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FUNCTIONAL CHECK AND MAINTENANCE. 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 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 IN-LINE FILTER PROX IS CONTAMINATED, AIR INLET FOAM FILTER REPLACED DUE TO PREVENTIVE MAINTENANCE. THE 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 22479033 ↗
• MalfunctionJul 2, 2025Mechanical Problem; Mechanical Problem

  A TRILOGY EVO 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, "SERVICE REQUIRED" CODES E-147 AND E-149 WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG INDICATING THE O2 FLOW SENSOR RAILED TO MAXIMUM NEGATIVE VALUE AND O2 FLOW COMMUNICATION CEASED AND THE SENSOR IS REPORTING THE SAME VALUE. THE DEVICE'S OXYGEN BLENDING MODULE BOARD ASSEMBLY REQUIRED REPLACEMENT TO ADDRESS THE ISSUE. AFTER REPAIR, THE DEVICE PASSED FINAL TESTING AND WAS CONFIRMED TO BE OPERATING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382397 ↗
• MalfunctionJun 13, 2025Failure to Calibrate; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, IT WAS DETERMINED THE OXYGEN BLENDING MODULE ASSEMBLY REQUIRED REPLACEMENT DUE TO CRITICAL SERVICE REQUIRED CODES THAT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201272 ↗
• MalfunctionMay 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "FAN NOT OPERATIONAL" CONDITION HAD OCCURRED ON A LIFEVENT EVO2 DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090244 ↗
• MalfunctionMay 23, 2025Electrical /Electronic Property Problem; Insufficient Device Problem Information; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A LIFEVENT EVO2 VENTILATOR IS IN AN INOPERATIVE CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077481 ↗
• MalfunctionJan 29, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALFUNCTION OF A TRILOGY EVO VENTILATOR¿S ACTIVE EXHALATION TEST STEP FAILED. NO HARM OR INJURY WAS REPORTED. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, THIS EVENT IS REPORTABLE BECAUSE THE FAILURE COULD AFFECT THE ABILITY OF THE DEVICE TO PROVIDE THERAPY TO PUBLISHED SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. THEREFORE, THE ALLEGED MALFUNCTION IS NOT ABLE TO BE CONFIRMED AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265605 ↗
• MalfunctionOct 4, 2024Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM INVOLVING THE INTERNAL BATTERY OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370717 ↗
• MalfunctionOct 4, 2024Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM INVOLVING THE INTERNAL BATTERY OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370477 ↗
• MalfunctionMay 2, 2024Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234782 ↗
• MalfunctionApr 29, 2024Charging Problem; Charging Problem

  THE TRILOGY DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. 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 19200091 ↗
• MalfunctionMar 11, 2024Mechanical Problem; Mechanical Problem

  A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AN ACTIVE EXHALATION OCCURRED. THE UNIT DOES NOT CONNECT TO THE TRILOGY EVO SERVICE TOO AND ERRORS CAN'T BE READ. IN-LINE FILTER IS CONTAMINATED. AIR INLET FOAM FILTER WILL BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882997 ↗
• MalfunctionFeb 8, 2024Mechanical Problem; Mechanical 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 "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE HARNESS WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668698 ↗
• MalfunctionJan 9, 2024Circuit Failure; Battery Problem; Circuit Failure; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INTERNAL BATTERY FAILURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477385 ↗
• MalfunctionDec 5, 2023Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A LIFEVENT EVO2 DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270591 ↗
• MalfunctionNov 28, 2023Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED AN ALLEGATION OF THE DEVICE NOT FUNCTIONING AND A "NOT OPERATING VENTILATOR" MESSAGE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18219391 ↗
• MalfunctionSep 11, 2023Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR PRESSURE SENSOR RAILED ERROR ALARM OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719674 ↗