Trilogy IT2110X21BRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00606959055421), received between Mar 28, 2023 and Sep 30, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (14 reports).

5 FDA recall records name this device's identifier, 5 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-0291-2025 · 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-1504-2024 · Root cause: Device Design · FDA record ↗

4. Nov 27, 2023Open, Classified

   The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

   Z-0638-2024 · Root cause: Device Design · FDA record ↗

5. 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure; Electrical /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, a critical event code that indicates the power VBUS dropped was recorded in the event log; the system printed circuit board assembly was replaced. Preventative maintenance was completed. Cosmetic damage was reported and components replaced. The device passed final testing and was returned to the customer.Additional findings not related to the malfunction/issue: A non-critical event code was noted in the event log indicating replacement of the machine flow was sensor was required; the machine flow sensor was replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951504 ↗
• MalfunctionJun 2, 2026Electrical /Electronic Property Problem; Device Sensing Problem; Device Contamination with Chemical or Other Material

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MAINTENANCE REQUIRED OCCURRED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 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, PRESSURE SENSOR MISMATCH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND FOUND CONTAMINATION ON THE MACHINE FLOW SENSOR AND IN-LINE PROXIMAL FILTER. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR 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 FOAM INLET FILTER, MUFFLER, AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE SYSTEM PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS ANOTHER ERROR CODE, PRESSPAIR ERROR, THAT WAS FOUND IN THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363760 ↗
• MalfunctionMay 27, 2026Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR MAINTENANCE SERVICE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT REPORTED 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. A ¿VENT SERVICE REQUIRED¿ ALARM ERROR WAS OBSERVED INDICATING THE DEVICE SOFTWARE DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS. THE INVESTIGATION DETERMINED THAT THE CONDITION WAS CAUSED BY CONTAMINATION WITHIN THE BLOWER ASSEMBLY, BLOWER BELLOWS SEAL, MACHINE FLOW SENSOR, FIO2 TUBING, AND IN-LINE FILTER PROX. TO ADDRESS THE ISSUE, THE MACHINE FLOW SENSOR, BLOWER ASSEMBLY, AND BLOWER BELLOWS WERE REPLACED. ADDITIONALLY, A DEBUG ERROR ASSOCIATED WITH TRANSIENT SENSOR EVENTS WAS IDENTIFIED DURING THE EVALUATION. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO CORRECT THE ISSUE. DUE TO THE 4-YEAR PREVENTIVE MAINTENANCE, THE AIR INLET FOAM FILTER, PARTICULATE FILTER AND MUFFLER ASSEMBLY WERE REPLACED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302790 ↗
• MalfunctionApr 28, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED ALARM HAD OCCURRED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 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, BATTERY NOT CHARGING FAULT AND SOFT POWER FAIL, ERROR CODES WERE OBSERVED IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DETACHABLE BATTERY HAD CAUSED THE SERVICE REQUIRED ALARM TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S DETACHABLE BATTERY NEEDS 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 AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTED ISSUE. ONE OF THE IN-LINE PROXIMAL FILTERS WAS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020859 ↗
• MalfunctionApr 14, 2026Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD PARTY FOR SERVICE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. THE TRILOGY EVO DEVICE WAS EVALUATED BY THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION, A VENTILATOR INOPERATIVE ERROR CODE RELATED TO A FAILURE IN THE MACHINE'S FLOW SENSOR WAS OBSERVED. IN CONCLUSION, THE MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874233 ↗
• MalfunctionMar 24, 2026Failure to Calibrate; Pressure Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE, WITH AN ALLEGATION OF MAINTENANCE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING EVALUATION OF THE TRILOGY EVO BY THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO PRESSURE WAS FOUND IN THE ERROR LOG. 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 DEVICE ALSO FAILED THE INTERNAL FLOW VERIFICATION TEST STEP DURING FUNCTIONAL TESTING. THE DEVICE'S MACHINE FLOW SENSOR HAS BEEN REPLACED TO ADDRESS BOTH ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675694 ↗
• MalfunctionMar 19, 2026Battery Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. THE DEVICE EVALUATION FOUND ERROR CODES RELATED TO THE BATTERY. EVT_BATTERY_NOT_CHARGING_FAULT AND EVT_TOTAL_BATTERY_LOW REFERENCE THAT THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THAN OR EQUAL TO 1 MINUTE. THE DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640583 ↗
• MalfunctionMar 19, 2026Contamination; Mechanical Problem; Failure to Calibrate

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED AN ACTIVE EXHALATION VERIFICATION TEST STEP DURING TESTING. TWO IN-LINE FILTERS PROX WERE FOUND TO BE CONTAMINATED WITH DIRT AND WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RE-TESTED AND PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639843 ↗
• MalfunctionMar 17, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS EVALUATED WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR COMPLETION OF REQUIRED MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, A VENTILATOR INOPERATIVE ERROR CODE E-155 WAS NOTED IN THE ERROR LOG INDICATING THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION. THE OXYGEN FLOW SENSOR WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE FAILED FUNCTIONAL TESTING FOR A FAILED MACHINE FLOW SENSOR. THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THIS ISSUE. THE SCHEDULED 4-YEAR DEVICE MAINTENANCE WAS COMPLETED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: AN EVENT CODE WAS NOTED IN THE DEVICE LOG INDICATING THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. 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 24619075 ↗
• MalfunctionMar 2, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR MAINTENANCE SERVICING. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR OCCURRED. THE SERVICE TECHNICIAN STATES THAT THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DISPLAY PCA IS DEFECTIVE AND NEEDS TO BE REPLACED. THE AIR FOAM INLET FILTER, PARTICULATE FILTER, AND MUFFLER WERE REPLACED FOR MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489125 ↗
• MalfunctionFeb 4, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MAINTENANCE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MACHINE FLOW SENSOR WAS OBSERVED IN THE ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFTED ABOVE THE SPECIFICATION (>0.2LPM). THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE REPORTABLE ERROR, DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO THE MOTOR CONTROLLER WAS OBSERVED IN THE ERROR LOG. EVT_MCL_FOC_SHUTDOWN MEANS THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER WAS REPLACED TO ADDRESS THE ISSUE. ALSO, AN ERROR CODE RELATED TO THE SENSOR OFFSET WAS OBSERVED. EVT_DRIFT_DEBUG MEANS SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH. THE REPLACEMENT OF THE MACHINE FLOW SENSOR WOULD ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259432 ↗
• MalfunctionJan 23, 2026Pressure Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE WITH A REPORTED ISSUE OF 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 IN THE ERROR LOG. 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 DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE ISSUE, BUT NECESSARY PARTS WERE REPLACED AS IF PREVENTIVE MAINTENANCE WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162703 ↗
• MalfunctionJan 22, 2026Battery Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO THE BATTERY WAS OBSERVED. EVT_BATTERY_NOT_CHARGING_FAULT MEANS THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THAN OR EQUAL TO 1 MINUTE. THE DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145281 ↗
• MalfunctionDec 22, 2025Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MAINTENANCE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO THE BATTERY CHARGING WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. EVT_BATTERY_NOT_CHARGING_FAULT MEANS THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DIE TO A HARDWARE FAULT FOR GREATER THAN OR EQUAL TO ONE MINUTE. THE DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865837 ↗
• MalfunctionNov 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY EVO DEVICE IS NOT OPERATING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE THIRD-PARTY SERVICE CENTER AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622348 ↗
• MalfunctionNov 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 23467074 ↗
• MalfunctionAug 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "VENTILATOR NOT OPERATIVE" ALARM OCCURRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO VENTILATOR HAS NOT YET BEEN RECEIVED AT THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED "VENTILATOR NOT OPERATIVE" ALARM. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840057 ↗
• MalfunctionJun 25, 2025Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED ALONG WITH A REQUEST FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS REPORTED TO BE IN PATIENT USE. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY 'S SERVICE CENTER ERROR CODES RELATED TO FAILURE OF THE INTERNAL LI-ION BATTERY WAS OBSERVED. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S INTERNAL BATTERY TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE'S MUFFLER ASSEMBLY, AIR FOAM INLET FILTER, AND PARTICULATE FILTER WILL BE REPLACED ACCORDING TO THE 4 YEAR PREVENTIVE MAINTENANCE PROCEDURE. 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 22328464 ↗
• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REQUIRED MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURY OR HARM WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, ERROR CODES RELATED TO THE INTERNAL BATTERY WERE CONFIRMED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE INTERNAL LI-ION BATTERY REQUIRED REPLACEMENT TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE DETACHABLE BATTERY WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED DUE TO AN ERROR CODE (E-290) INDICTING A START/STOP KEY LATCH FAILURE. AS PART OF MAINTENANCE THE BLOWER, LOW FLOW OXYGEN TUBING, MACHINE FLOW SENSOR, A PROXIMAL IN-LINE FILTER AND THE IN-LINE FILTER WERE ALL REPLACED FOR CONTAMINATION. FOUR-YEAR MAINTENANCE SERVICE WAS COMPLETED WITH FILTER REPLACEMENTS PER MAINTENANCE SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326841 ↗
• MalfunctionApr 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER A VENTILATOR INOPERATIVE CODE WAS FOUND RELATED TO THE USER INTERFACE SOFTWARE VERSION STRING NOT MATCHING THE OVERALL SYSTEM VERSION STRING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE THIRD PARTY SERVICE TECHNICIAN OBSERVED THE VENTILATOR INOPERATIVE USER INTERFACE SOFTWARE MISMATCH CODE IN THE DEVICE'S EVENT LOG. THE TECHNICIAN REPLACED THE DEVICE'S SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD TO ADDRESS THE ERROR CODE. IN ADDITION, A MOTOR CONTROLLER SHUTDOWN ERROR CODE WAS ALSO FOUND IN THE DEVICE LOG. THE BLOWER WAS REPLACED TO RESOLVE THE ISSUE. A VENTILATOR SERVICE REQUIRED ERROR CODE RELATING TO AN OUTLET PRESSURE SENSOR RAILED TO MAXIMUM NEGATIVE VALUE ALSO APPEARED IN THE DEVICE'S LOG. THE REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD RESOLVED THE ERROR. THE AIR FOAM INLET FILTER, PARTICULATE FILTER, AND MUFFLER WILL BE REPLACED DUE TO THE 4 YEAR PREVENTATIVE MAINTENANCE PROCEDURE. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770364 ↗
• MalfunctionApr 3, 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 HAS NOT BEEN RETURNED TO THE MANUFACTURER. 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 21764239 ↗
• MalfunctionNov 5, 2024Device Sensing Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED AN ALLEGATION THAT DURING A SOFTWARE UPDATE, THE DEVICE DISPLAYED A PRESSURE SENSOR MISMATCH ERROR. TO BE REPAIRED, THE DEVICE MUST RETURN TO THE CUSTOMER LABORATORY AND THE FLOW SENSOR MUST BE REPLACED ABOUT 2 HOURS LABOR. THE CUSTOMER NEEDS A BACKUP DEVICE. THE MANUFACTURER IS CURRENTLY WORKING ON SENDING A BACKUP DEVICE. 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 20613145 ↗
• MalfunctionOct 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PRESCRIPTION IS NOT SAVING PROPERLY AFTER TURNING THE DEVICE ON LESS THAN THIRTY MINUTES AFTER PERFORMING A SHUTDOWN ON THE 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 20457166 ↗
• MalfunctionOct 7, 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 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 20383983 ↗
• MalfunctionApr 22, 2024Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP. 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 19155665 ↗