Trilogy Evo AU2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00606959051980), received between Dec 29, 2022 and May 5, 2026 — classified as 3 deaths, 3 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (17 reports).

3 FDA recall records name this device's identifier, 3 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. ANALYSIS OF THE LOGS IDENTIFIED A "VENT SERVICE REQUIRED" ALARM INDICATING THAT THE INTERNAL OR DETACHABLE LI-ION BATTERY WAS NOT CHARGING DUE TO A HARDWARE FAULT FOR A DURATION OF ONE MINUTE OR MORE. TO RESOLVE THIS ISSUE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) AND BATTERY WERE REPLACED. ADDITIONALLY, THE BATTERY MUFFLER WAS REPLACED DUE TO DUST, AND THE FILTER WAS REPLACED DUE TO CONTAMINATION. THE DEVICE FILTERS AND FILTER CAP WERE ALSO REPLACED. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081284 ↗
• MalfunctionApr 8, 2026Computer Software Problem; Electrical /Electronic Property Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION STATING A TRILOGY EVO VENTILATOR INOPERATIVE CONDITION OCCURRED DURING A FAILED FIRMWARE UPDATE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER EVALUATION. THE MANUFACTURE'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 24820860 ↗
• MalfunctionApr 8, 2026Computer Software Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION STATING A TRILOGY EVO VENTILATOR INOPERATIVE CONDITION OCCURRED DURING A FAILED FIRMWARE UPDATE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER EVALUATION. THE MANUFACTURE'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 24820852 ↗
• MalfunctionApr 8, 2026Computer Software Problem; Electrical /Electronic Property Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION STATING A TRILOGY EVO VENTILATOR INOPERATIVE CONDITION OCCURRED DURING A FAILED FIRMWARE UPDATE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER EVALUATION. DURING THE EVALUATION THE FIRMWARE WAS SUCCESSFULLY UPGRADED, AND BOTH THE INTERNAL AND DETACHABLE BATTERIES FAILED TO CHARGE SIMULTANEOUSLY. THE MANUFACTURE'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 24820367 ↗
• MalfunctionMar 20, 2026Circuit Failure; Operating System Version or Upgrade Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION STATING A TRILOGY EVO VENTILATOR INOPERATIVE CONDITION OCCURRED DURING A FAILED FIRMWARE UPDATE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE, THE SYSTEM BOARD WAS REPLACED, AND ALL VENTILATOR SETTINGS WERE REPLACED WITH THE WORK ¿VALUE¿ TO ADDRESS THE ISSUE. THE ROOT CAUSE WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651798 ↗
• MalfunctionJan 16, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE ERROR CODE WAS FOUND DURING SERVICE 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 BEING EVALUATED AT THE MANUFACTURER SERVICE CENTER WHEN THE REPORTED ISSUE WAS FOUND ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, THERAPY HELD IN BM (E-0156), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) AND TUBING-SYSTEM PCA HAD CAUSED THE REPORTABLE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA AND TUBING-SYSTEM PCA WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TUBING/HOUSING, TUBING BLOWER CHASSIS, AND TUBING/HOUSING TUBING FIO2 WERE REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE MUFFLER AND POWER CORD WERE REPLACED FOR BEING OUT SPECIFICATION WHICH WAS UNRELATED TO THE REPORTABLE ISSUE. THE INTERNAL BATTERY DOOR WAS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098184 ↗
• MalfunctionJan 16, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO AUSTRALIA, DEVICE AT THIRD-PARTY SERVICE CENTER, A "PRESSURE SENSOR MISMATCH" ERROR CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S (FLOW ELEMENT/SENSOR) MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE ISSUE THE DEVICE'S MUFFLER, BATTERY AND TUBING-SYSTEM WERE REPLACED AS PER FC. THE DEVICE'S TUBING-SYSTEM PCA, TUBING-FIO2 TUBING/HOUSING AND TUBING-BLOWER CHASSIS ARE CONTAMINATED. THE DEVICE'S MUFFLER, TUBING/HOUSING, AND FIO2TUBING/HOUSING HAVE BEEN REPLACED TO ADDRESS THIS ISSUE. THE POWER CORD WAS REPLACED DUE TO BEING OUT OF SPEC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097067 ↗
• DeathJan 8, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT RECENTLY DECEASED AND SUBJECT TO CURRENT CORONERS REVIEW. NO CAUSE AND/OR CONTRIBUTION OF THE DEVICE TO THE PATIENT EXPIRATION WAS ALLEGED AND NO HARM OR INJURY HAS BEEN REPORTED. REQUEST HAS BEEN MADE TO SEND THE DEVICE TO THE PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION. DEVICES IS STILL WITH THE DECEASED DUE TO A FORMAL CORONIAL INVESTIGATION. IT IS ANTICIPATED THAT DEVICE WILL BE MADE AVAILABLE TO PHILIPS FOR ASSESSMENT IN THE NEAR FUTURE. GOOD FAITH EFFORTS FOR ADDITIONAL INFORMATION ARE CURRENTLY IN PROGRESS. 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: Insufficient Information

  MAUDE report 24007857 ↗
• DeathJan 8, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT RECENTLY DECEASED AND SUBJECT TO CURRENT CORONERS REVIEW. NO CAUSE AND/OR CONTRIBUTION OF THE DEVICE TO THE PATIENT EXPIRATION WAS ALLEGED AND NO HARM OR INJURY HAS BEEN REPORTED. REQUEST HAS BEEN MADE TO SEND THE DEVICE TO THE PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION. DEVICES IS STILL WITH THE DECEASED DUE TO A FORMAL CORONIAL INVESTIGATION. IT IS ANTICIPATED THAT DEVICE WILL BE MADE AVAILABLE TO PHILIPS FOR ASSESSMENT IN THE NEAR FUTURE. GOOD FAITH EFFORTS FOR ADDITIONAL INFORMATION ARE CURRENTLY IN PROGRESS. 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: Insufficient Information

  MAUDE report 24007848 ↗
• MalfunctionDec 30, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE WAS FOUND ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, BATTERY NOT CHARGING FAULT (E-059), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN EVALUATED AND FOUND THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE ERROR CODE ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE LIQUID CRYSTAL DISPLAY (LCD) WAS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927740 ↗
• MalfunctionOct 28, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING SYSTEM LEAK VERIFICATION TEST STEP HAD FAILED 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 EVALUATED AT THE MANUFACTURER SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES MUFFLER ASSEMBLY HAD CAUSED THE SYSTEM LEAK TEST STEP TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MUFFLER ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408031 ↗
• MalfunctionOct 20, 2025Electrical /Electronic Property Problem; Pressure Problem; Electrical /Electronic Property Problem; Pressure 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE RELATED TO A PRESSURE DROP WAS OBSERVED. EVT_PRESS_SENSOR_MISMATCH MEANS THE DEVICE SOFTWARE DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE FLOW ELEMENT/SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE REPORTABLE ERROR CODE, DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE MUFFLER, TUBING-BLOWER CHASSIS AND TUBING-FIO2 WERE FOUND TO BE CONTAMINATED. NO REPORT THAT CONTAMINATION CAUSED ANY OTHER MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337182 ↗
• MalfunctionSep 2, 2025Display or Visual Feedback Problem; Charging Problem; Display or Visual Feedback Problem; Charging Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ERROR CODE THAT REQUIRED THE REPLACEMENT OF THE DISPLAY AND AN ERROR CODE RELATED TO THE CHARGING OF THE BATTERY, WHICH REQUIRED REPLACEMENT OF THE SYSTEM BOARD. THERE WAS NO HARM OR INJURY REPORTED. EVT_BATTERY_NOT_CHARGING_FAULT - THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THAN OR EQUAL TO 1 MINUTE. THE DISPLAY WAS REPLACED TO ADDRESS THE UNKNOWN ERROR CODE AND THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ERROR CODE RELATED TO THE CHARGING OF THE BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938751 ↗
• MalfunctionJul 30, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property 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 EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, A "VENTILATOR SERVICE REQUIRED" (EVT_BATTERY_NOT_CHARGING_FAULT) CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR 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 PARTICULATE FILTER IS CONTAMINATED, AND THE FILTER(S) AND FILTER CAP WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665695 ↗
• MalfunctionJul 7, 2025Complete Loss of Power; Complete Loss of Power

  A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A FAILURE OF THE DEVICE TO POWER ON WAS OBSERVED. THE DEVICE'S POWER SUPPLY/POWER CORD WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION, THE FIO2 TUBING WAS REPLACED. CONTAMINATION WAS OBSERVED THEREFORE THE TUBING, HOUSING, FILTER(S)/FILTER CAP, FILTER COVER WERE REPLACED. THE FOLLOWING PARTS WERE BROKEN THEREFORE WERE REPLACED, FILTER(S)/FILTER CAP. AS A PART OF SERVICE, THE PARTICULATE FILTER WAS REPLACED. THE TECHNICIAN CONFIRMED THAT THERE WAS NO PROBLEM FOUND AND REPLACED OTHER THERE IS NO OTHER INFORMATION PROVIDED AT THIS TIME. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE TO DETERMINE THE ACTUAL FAILURE OR REASON WHY OTHER PARTS WERE REPAIRED/REPLACED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413795 ↗
• DeathJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A LOANER TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER DUE TO A PATIENT PASSING AWAY. IT WAS NOTED THAT THE PATIENT WAS NOT ON THE DEVICE AT THE TIME OF DEATH AND THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND NO ACTIONABLE ERROR CODES OR MALFUNCTIONS WERE OBSERVED. THE UNIT WAS CALIBRATED AND CONFIRMED TO BE WORKING CORRECTLY. OPERATION HRS = 0.8 / BLOWER HRS = 0.8. IN ADDITION, THE TECHNICIAN REPLACED THE AIR INLET FILTER & PARTICULATE FILTER. THE UNIT WAS DECONTAMINATED BEFORE RETURNING TO THE ENABLE ROOM. THE SOFTWARE VERSION 1.06.10.00. PHILIPS WAS NOTIFIED THAT THE PATIENT PASSED AWAY ON 21/5. THE DEVICE ARRIVED IN NR ON 23/5 WITHOUT THE POWER CORD OR BAG. HEALTHSHARE TO BE INFORMED THAT THESE ACCESSORIES WILL NEED TO BE REPLACED. THIS EVENT WAS REVIEWED BY THE MANUFACTURER CLINICAL ASSESSMENT TEAM AND WAS DETERMINED: THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USER ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARM REPORTED. ADDITIONALLY, THERE IS NO OTHER CLINICAL INFORMATION PROVIDED TO INDICATE ANY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353129 ↗
• MalfunctionMay 28, 2025Charging Problem; Charging Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, AN EVT_BATTERY_NOT_CHARGING_FAULT ERROR WAS DISCOVERED IN THE EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S SYSTEM BOARD TO ADDRESS THE ISSUE. ADDITIONALLY, THE MUFFLER AND THE FLOW ELEMENT/SENSOR WERE REPLACED DUE TO REPORTED AS HAVING BEEN DIRTY/ CONTAMINATED. THE TUBING-FIO2 IS CONTAMINATED SO THE TUBING/HOUSING WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099614 ↗
• MalfunctionApr 4, 2025Failure to Calibrate; Failure to Calibrate

  A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S 3-WAY SOLENOID VALVE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: DUE TO CONTAMINATION, THE DUST FILTER/FILTER CAP AND FIO2 TUBING WERE REPLACED. THE HOUSING WAS ALSO REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774881 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS A REPLACING THE MUFFLER AND SCREW ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279837 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS A FAILURE OF THE BATTERY COMPONENT, BATTER PRINTED CIRCUIT ASSEMBLY, AND WIRING/HARNESS. THESE PARTS WERE REPLACED ON THE DEVICE TO ADDRESS THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274762 ↗
• MalfunctionJan 30, 2025Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER'S FACTORY AUTHORIZED SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" ALARM CODE INDICATING AN INTERNAL BATTERY FAILURE WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S POWER CORD, INTERNAL BATTERY AND MAIN PCA BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE ABOVE ISSUE, THE DEVICE WAS ALARMING FOR A DETACHABLE BATTERY ISSUE. THE DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273625 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER'S FACTORY AUTHORIZED SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" ALARM CODE INDICATING A SENSOR MISMATCH ERROR WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE ABOVE ISSUE, THE DEVICE'S INTERFACE BOARD WAS FOUND TO BE DAMAGED AND WAS REPLACED. THE DEVICE'S MUFFLER WAS LEAKING AND WAS REPLACED. ADDITIONAL PATIENT SETTINGS AND EVENT ALARMS WERE NOTED IN THE DEVICE'S DOWNLOADED EVENT LOG THAT ARE NON-REPORTABLE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273343 ↗
• MalfunctionOct 29, 2024Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE INTERNAL BATTERY IS NOT CHARGING ON A VENTILATOR. ADDITIONALLY, THE DETACHABLE BATTERY HAS SHOWN SEVERAL INSTANCES OF DEPLETION. IT CURRENTLY HAS ONE LED WHEN TESTED AND HAS BEEN ON CHARGE FOR A COUPLE OF HOURS. 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 20563818 ↗
• MalfunctionOct 28, 2024Battery Problem; Battery Problem

  A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH THE ALLEGATION THAT CRITICAL ERRORS OCCURRED. THERE WAS NO HARM OR INJURY 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 SYSTEM PRINTED CIRCUIT ASSEMBLY NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552797 ↗
• MalfunctionOct 28, 2024Battery Problem; Battery Problem

  A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH THE ALLEGATION THAT CRITICAL ERRORS OCCURRED. THERE WAS NO HARM OR INJURY 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, DETACHABLE BATTERY, DETACHABLE BATTERY INTERFACE PRINTED CIRCUIT ASSEMBLY AND SYSTEM PRINTED CIRCUIT ASSEMBLY NEEDED REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551229 ↗