Trilogy Evo GB2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 00606959054127), received between Jan 13, 2021 and Sep 30, 2026 — classified as 1 death, 2 injuries, 138 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (77 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 7, 2024Class IOpen, 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 · Recall details · FDA record ↗

2. Jul 16, 2024Class IOpen, 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 · Recall details · FDA record ↗

3. Mar 19, 2024Class IOpen, 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 · Recall details · FDA record ↗

4. Nov 27, 2023Class IIOpen, 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 · Recall details · FDA record ↗

5. May 1, 2023Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The manufacturer received a report that a Trilogy EVO ventilator was returned for service. No patient harm or injury was reported.The device was evaluated at a third-party service center. The device log files were successfully downloaded and reviewed in full. Review of the logs identified a Vent Service Required error indicating that the device software detected a large pressure drop between the monitor and outlet pressure sensors. The air pathway was inspected for environmental debris and contamination; no debris or contamination was identified. Service documentation did not identify the component replaced to address this condition. Additional error conditions, unrelated to the reported malfunction, were identified during the evaluation. An error related to the machine flow sensor offset being greater than 0.2 SLPM was identified. In accordance with the service manual, the machine flow sensor was replaced.An error related to the main outlet pressure sensor encountering an error condition was also identified requiring replacement of the System Printed Circuit Assembly (PCA).An error related to the sensor offset during drift calculation being too high was identified. A pneumatic gro

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951013 ↗
• MalfunctionJun 23, 2026Electrical /Electronic Property Problem

  A TRILOGY EVO, GREAT BRITAIN DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION DUE TO SERVICE REQUIRED. THERE WAS NO ALLEGATION OF PATIENT HARM. DURING THE EVALUATION, ERROR EVT_PRESS_SENSOR_MISMATCH (ERROR CODE 384) WAS FOUND IN THE DEVICE ERROR CODE LOG. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THIS ERROR CODE. ADDITIONALLY, ERROR EVT_PRESSPAIR_ERR (ERROR CODE 170) AND ERROR EVT_DRIFT_DEBUG (ERROR CODE 330) WERE FOUND IN THE DEVICE ERROR CODE LOG, AND THE PRINTED CIRCUIT ASSEMBLY NEEDS TO BE REPLACED TO ADDRESS THESE ERROR CODES. ERROR EVT_MACH_FLOW_DRIFT_LOG (ERROR CODE 386) WAS ALSO FOUND IN THE DEVICE ERROR CODE LOG, AND THE MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THIS ERROR CODE. THE SERVICE TECHNICIAN NOTED THAT ALL OTHER ERRORS WERE CAUSED BY CONTAMINATION. THE BLOWER ASSY, TUBING BLOWER CHASSIS AND TUBING FIO2 WERE CONTAMINATED WITH DIRT, AND THE AIR FOAM INLET FILTER, MUFFLER, AND PARTICULATE FILTER NEED REPLACED DUE TO 4-YEAR PM. AFTER THE EVALUATION AND REWORK WERE COMPLETE, THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600171 ↗
• MalfunctionJun 22, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE INITIAL EVALUATION OF THE DEVICE A VENTILATOR INOPERATIVE ALARM INDICATING A SYSTEM BOARD FAILURE WAS OBSERVED IN THE EVENT LOG. A SERVICE REQUIRED ALARM INDICATING THE INTERNAL BATTERY WAS NOT DETECTED WAS ALSO OBSERVED. THE DEVICE'S SYSTEM BOARD AND INTERNAL BATTERY NEED TO BE REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE THE MACHINE FLOW SENSOR NEEDS TO BE REPLACED DUE TO CONTAMINATION. 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 FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578674 ↗
• MalfunctionJun 17, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE DUE TO A VENTILATOR INOPERABLE ALARM. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED A VENTILATOR INOPERATIVE ERROR CODE E155 (EVT_MACH_FLOW_DRIFT_HIGH) IN THE ERROR LOG. THIS ERROR INDICATED MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (>0.2LPM). THE FLOW SENSOR WILL BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE INTERNAL BATTERY DOOR WAS DAMAGED, PREVENTATIVE MAINTENANCE REPLACEMENT OF THE AIR FOAM INLET FILTER, MUFFLER, AND PARTICULATE FILTER. THE PM LABEL WILL BE ADDED TO THE UNIT AND THE DATA IDENTIFIED ADDITIONAL ERROR CODES E144 (EVT_MCL_FOC_SHUTDOWN) AND E030 (EVT_HIGH_RESPIRATORY_RATE), THEREFORE, THE SYSTEM PCA WILL NEED TO BE REPLACED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530848 ↗
• MalfunctionJun 16, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "VENTILATOR INOP" CONDITION INVOLVING A TRILOGY EVO DEVICE IN GREAT BRITAIN WHILE THE DEVICE WAS REPORTED TO BE IN PATIENT USE. NO PATIENT HARM OR INJURY WAS REPORTED. DURING IN-PROCESS EVALUATION AT A THIRD-PARTY SERVICE CENTER, THE DEVICE ERROR LOG COULD NOT BE RETRIEVED. DIAGNOSTIC TESTING WAS PERFORMED USING A KNOWN-GOOD ("GOLD") SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA), AND THE "VENTILATOR SERVICE REQUIRED" MESSAGE WAS NOT OBSERVED DURING TESTING. BASED ON THESE FINDINGS, REPLACEMENT OF THE DEVICE'S SYSTEM PCA WAS RECOMMENDED. ADDITIONALLY, THE AIR FOAM INLET FILTER AND PARTICULATE FILTER WERE IDENTIFIED FOR REPLACEMENT IN ACCORDANCE WITH THE PREVENTIVE MAINTENANCE PROCEDURE. THE DEVICE IS OUT OF WARRANTY AND IS CURRENTLY AWAITING CUSTOMER APPROVAL FOR REPAIR. A FINAL REPORT IS BEING SUBMITTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING COMPLETION OF THE DEVICE REPAIR THAT IMPACTS THE INVESTIGATION FINDINGS OR MEDICAL DEVICE REPORTING DETERMINATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523575 ↗
• MalfunctionJun 5, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED 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, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DETACHABLE BATTERY HAD CAUSED THE SERVICE REQUIRED TO OCCUR ON THE TRILOGY EVO DEVICE. IN CONCLUSION, THE DETACHABLE BATTERY NEEDS REPLACED TO ADDRESS THE REPORTED ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY NEEDS REPLACED TO ADDRESS ANOTHER ERROR CODE, PRESS PAIR ERROR, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE MACHINE FLOW SENSOR AND TWO OF THE IN-LINE PROXIMAL FILTERS NEED REPLACING DUE TO CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE AIR FOAM INLET FILTER, MUFFLER, AND PARTICULATE FILTER NEED REPLACING DUE TO PREVENTATIVE MAINTENANCE UNRELATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414106 ↗
• MalfunctionJun 5, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION SERVICE 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, BATTERY NOT CHARGING FAULT, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED BUT WAS NOT ABLE TO DETERMINE THE CAUSE OF THIS ERROR CODE THAT OCCURRED ON THE DEVICE. 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. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR FOAM INLET FILTER, PARTICULATE FILTER, AND MUFFLER WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410128 ↗
• MalfunctionJun 5, 2026Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED 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 MANUFACTURER 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 EVALUATED AND DETERMINED THAT THE MACHINE FLOW SENSOR HAD CAUSED THE SERVICE REQUIRED TO OCCUR ON THE TRILOGY EVO DEVICE. IN CONCLUSION, THE MACHINE FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER NEEDS REPLACING TO ADDRESS ANOTHER SYSTEM ERROR, EVENT MOTORCONTROL FORCE SHUTDOWN, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS REPLACED TO ADDRESS ANOTHER ERROR CODE, DRIFT DEBUG, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409732 ↗
• MalfunctionJun 1, 2026Device Sensing Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER DUE TO A SERVICE REQUIRED ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION A PRESSURE SENSOR MISMATCH ALARM CONDITION WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. NO CONTAMINATION OF THE DEVICE WAS NOTED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351167 ↗
• MalfunctionMay 21, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. DURING BENCH RUN- IN TESTING, A ¿VENT SERVICE REQUIRED¿ ALARM WAS OBSERVED. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. REVIEW OF THE LOGS IDENTIFIED A ¿VENT SERVICE REQUIRED¿ ERROR INDICATING THAT THE DEVICE SOFTWARE DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS. THE AIR PATHWAY WAS INSPECTED FOR ENVIRONMENTAL DEBRIS AND CONTAMINATION; NO DEBRIS OR CONTAMINATION WAS IDENTIFIED. AS A PRECAUTIONARY MEASURE, THE MACHINE FLOW SENSOR WAS REPLACED. SUBSEQUENT BENCH RUN-IN TESTING WAS PERFORMED, AND NO ADDITIONAL ALARMS WERE OBSERVED. INTERNAL AND EXTERNAL INSPECTIONS OF THE DEVICE WERE COMPLETED, WITH NO COSMETIC DAMAGE IDENTIFIED. AS PART OF PREVENTIVE MAINTENANCE, THE PARTICULATE FILTER, AIR INLET FOAM FILTER, AND MUFFLER ASSEMBLY WERE REPLACED. THE DEVICE PASSED ALL FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241570 ↗
• MalfunctionMay 20, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. A ¿VENTILATOR SERVICE REQUIRED¿ ALARM WAS IDENTIFIED DUE TO FAILURE OF THE INTERNAL BATTERY SYSTEM. SPECIFICALLY, THIS CONDITION MAY HAVE RESULTED FROM THE BATTERY NOT BEING DETECTED, FAILURE OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) AS INDICATED BY TERMINAL VOLTAGE, WAKE VOLTAGE, OR SMBUS COMMUNICATION ERRORS, OR AN INTERNAL BATTERY FAILURE. THE INTERNAL BATTERY WAS REPLACED TO CORRECT THE ISSUE. IN ADDITION, A ¿VENT INOPERATIVE¿ ERROR WAS IDENTIFIED, ATTRIBUTED TO THE THERAPY CPU REMAINING IN BOOT MONITOR SOFTWARE. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO CORRECT THE ISSUE. ADDITIONALLY, UNRELATED TO THE REPORTED MALFUNCTION, AN ERROR WAS OBSERVED RELATED TO THE DETACHABLE LI-ION BATTERY, INCLUDING A PERMANENT FAILURE INDICATION AND A CONDITION IN WHICH THE BATTERY WAS CONNECTED WITH V_WAKE_DET < 10.000V, POTENTIALLY ASSOCIATED WITH DETACHABLE BATTERY FAILURE, V_WAKE_

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230666 ↗
• MalfunctionMay 13, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE INVESTIGATION, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. A ¿VENTILATOR SERVICE REQUIRED¿ ALARM WAS IDENTIFIED ASSOCIATED WITH INTERNAL BATTERY CONNECTION ISSUES, INCLUDING V_WAKE_INT < 10.000V, POTENTIAL FAILURE OF THE V_WAKE_INT OR CHECK_WAKE_INT CIRCUITS, OR AN ANALOG-TO-DIGITAL CONVERTER (ADC) FAULT. AN EVENT ERROR WAS ALSO OBSERVED INDICATING V_BUS DROPPED BELOW 8.000V, WHICH MAY BE ASSOCIATED WITH DEPLETION OF ALL POWER SOURCES, A FAULT IN LAST POWER SOURCE, OR A POWER PATH CIRCUIT FAULT. NO DOCUMENTATION WAS PROVIDED CONFIRMING THAT ANY COMPONENTS WERE REPLACED TO ADDRESS THESE ERRORS. NO ADDITIONAL ACTIONABLE ERROR CODES WERE IDENTIFIED. THE REPORTED ISSUES WERE NOT REPLICATED DURING BENCH RUN-IN TESTING FOLLOWING PROPER DEPLETION AND RECHARGE OF THE DETACHABLE AND INTERNAL BATTERIES. PREVENTIVE MAINTENANCE WAS PERFORMED. BATTERY AND VALVE ASSESSMENTS PASSED. THE PARTICULATE FILTER, INLET FOAM FILTER, AND MUFFLER ASSEMBLY WERE REPLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164015 ↗
• MalfunctionMar 20, 2026Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR FAILED TO WORK ON AC. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651119 ↗
• MalfunctionMar 19, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION OF A SERVICE REQUIRED FOR A TRILOGY EVO, GREAT BRITAIN DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO, GREAT BRITAIN DEVICE AT THIRD-PARTY SERVICE CENTER, AN ERROR INDICATING THAT EITHER THE BACKLIGHT IN DISPLAY OR THE COMMUNICATION TO THE TOUCHSCREEN FAILED WAS DISCOVERED IN THE EVENT LOG. THE DEVICE'S DISPLAY BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE MALFUNCTION, THE DEVICE'S DETACHABLE BATTERY WAS NOT RETURNED WITH THE DEVICE; HOWEVER, IT SHOULD BE REPLACED TO ADDRESS AN EVT_DETACH_BATT_WAKE_VOLT_FAILED ERROR. THE SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS AN EVT_CAL_DATA ERROR. THE DEVICE'S COOLING FAN NEEDS TO BE REPLACED TO ADDRESS AN EVT_FAN1_FAILURE ERROR. AN ADDITIONAL ERROR, EVT_SW_UPGRADE_FAILURE, WAS DOCUMENTED DURING EVALUATION WITHOUT A DEFINITIVE COMPONENT IDENTIFIED FOR REPLACEMENT. THE DEVICE'S AIR INLET FOAM FILTER, PARTICULATE FILTER, AND MUFFLER ASSEMBLY NEED TO BE REPLACED TO MEET THE FOUR-YEAR PREVENTATIVE MAINTENANCE REQUIREMENT. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND HAS MET ACCEPTANCE CRITERIA IN ACCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637715 ↗
• MalfunctionMar 17, 2026Circuit Failure; Computer Software Problem; Electrical /Electronic Property Problem; Failure to Calibrate; Power Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION AN ALARM INDICATING ALL POWER SOURCES WERE DEPLETED WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL VENTILATOR INOPERATIVE ALARMS INDICATING A SOFTWARE MISMATCH WERE OBSERVED. THE DEVICE'S SOFTWARE WAS REINSTALLED TO ADDRESS THE ISSUES. THE DEVICE FAILED THE FINAL SHUTDOWN PROCEDURE, AND THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616327 ↗
• MalfunctionMar 13, 2026Circuit Failure; Computer Software Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR EXPERIENCED AN OUT OF BOX FAILURE DUE TO A SCREEN FREEZE. 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 CODE RELATING TO A 'SYSTEM VERSION MISMATCH USER INTERFACE' WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE LATEST SOFTWARE WAS INSTALLED TO ADDRESS THE ISSUE. ADDITIONALLY, THE SERVICE TECHNICIAN CONFIRMED THE OUT OF BOX FAILURE AND STATED THAT THE DISPLAY LIQUID CRYSTAL DISPLAY (LCD) WAS NOT FUNCTIONING. THE DISPLAY PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE SCREEN FREEZE. ADDITIONALLY, TWO NOT-REPORTABLE ERROR CODES RELATING TO 'INLET FILTER BLACK' AND 'COMMS FAIL USER INTERFACE' WERE FOUND IN THE DEVICE'S ERROR LOG. THE AIR INLET FOAM FILTER WAS REPLACED AND THE REPLACEMENT OF THE DISPLAY PCA RESOLVED BOTH OF THESE ERRORS. THE DEVICE PASSED TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589739 ↗
• MalfunctionJan 16, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A VENTILATOR INOPERATIVE ALARM OCCURRED WHILE IN PATIENT USE. A CRITICAL ERROR CODE IN RELATION TO "THERAPY CPU IS STILL RUNNING IN BOOT MONITOR SOFTWARE" WAS OBSERVED. 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 24092920 ↗
• MalfunctionDec 22, 2025Device Sensing Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "VENTILATOR SERVICE REQUIRED" ALARM OCCURRED ON A TRILOGY EVO. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. THE TRILOGY EVO 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 RELATED TO A FAILURE IN THE FLOW SENSOR DUE TO DEBRIS WAS RECORDED IN THE ERROR LOG. IN CONCLUSION, THE DEVICE'S FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874054 ↗
• MalfunctionDec 17, 2025Circuit Failure; Circuit Failure

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, AN ERROR CODE, EVT_SUPERCAP_FAILED, RELATED TO AN ISSUE WITH THE SUPERCAP OR THE CHARGING UNIT WAS OBSERVED. THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, THE BLOWER AND MACHINE FLOW SENSOR WERE FOUND TO BE CONTAMINATED WITH DUST. THERE WAS NO REPORT OF A MALFUNCTION OR ERROR CODE DUE TO THE DUST CONTAMINATION. THE BLOWER AND MACHINE FLOW SENSOR WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830462 ↗
• MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. 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 23816255 ↗
• MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, SEVERAL PATIENT SETTING ALARM CONDITIONS WERE OBSERVED. THE DEVICE'S DETACHABLE BATTERY WAS REPLACED TO ADDRESS A DETACHABLE BATTERY FAILURE. THE SYSTEM BOARD WAS REPLACED TO ADDRESS A SENSOR DRIFT DURING CALIBRATION. THE BLOWER ASSEMBLY WAS REPLACED DUE TO A MOTOR CONTROLLER SHUTDOWN. THESE ISSUES WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815620 ↗
• MalfunctionDec 8, 2025Electrical /Electronic Property Problem; Failure to Calibrate; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION OF DIAGNOSTIC TEST FAILURE ON SYSTEM SETUP. THERE WAS NO HARM OR INJURY REPORTED. ON EVALUATION, THE ERROR LOGS WERE DOWNLOADED AND EVALUATED. A VENTILATOR SERVICE REQUIRED ALARM WAS CONFIRMED INDICATING THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS. THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: FOUR-YEAR SERVICE WAS DUE ON THE DEVICE AND WAS COMPLETED. DURING REPAIR TESTING, THE DEVICE FAILED A TEST STEP FOR FIO2 SENSOR RECEPTACLE VERIFICATION. THIS TEST STEP VERIFIES THAT THE FIO2 SOLENOID IS OPEN, AND THE TUBING IS NOT KINKED OR OCCLUDED. THIS FIO2 SENSOR IS USED FOR MONITORING PURPOSES ONLY. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE FIO2 TUBING WAS REPLACED TO ADDRESS THIS ISSUE. RE-TESTING WAS COMPLETED WITH TESTS PASSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744094 ↗
• MalfunctionDec 2, 2025Electrical /Electronic Property Problem; Failure to Calibrate; Device Sensing Problem; Electrical /Electronic Property Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED PNEUMATIC TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE EVALUATION HAS NOT YET BEEN PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696902 ↗
• MalfunctionDec 2, 2025Circuit Failure; Contamination; Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem; Circuit Failure; Contamination; Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS CONTINUOUSLY ALARMING FOR A PRESSURE SENSOR MISMATCH ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS BEEN SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE EVALUATION HAS NOT YET BEGUN. IF ANY ADDITIONAL INFORMATION IS RECEIVED ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694573 ↗
• MalfunctionDec 1, 2025Failure to Calibrate; Device Sensing Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CALIBRATION FAILURE FOR A TRILOGY EVO, GREAT BRITAIN DEVICE, HOWEVER, THERE WAS NO INFORMATION OR DOCUMENTATION OF ANY REPORTABLE CALIBRATION FAILURE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO, GREAT BRITAIN DEVICE AT THIRD-PARTY SERVICE CENTER, IT IS DOCUMENTED THAT THE MACHINE FLOW SENSOR FAILS THE PNEUMATIC TEST. THE DEVICE'S MACHINE FLOW SENSOR HAS BEEN REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THERE ARE NO SIGNIFICANT ERRORS FOUND IN THE DEVICE LOG. ONE IN-LINE FILTER PROX HAS BEEN REPLACED DUE TO CONTAMINATION. THE DEVICE'S BLOWER IS CORRODED AND HAS BEEN REPLACED. DUE TO THE 4-YEAR PREVENTIVE MAINTENANCE, THE MUFFLER ASSEMBLY, PARTICULATE FILTER, MAINTENANCE LABEL AND AIR INLET FOAM FILTER WERE REPLACED. IT IS DOCUMENTED THAT THE DISPLAY WAS DAMAGED, BUT THERE IS NO INFORMATION TO THE EXTENT OR TYPE OF DAMAGE. THE DISPLAY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684629 ↗