Trilogy Trilogy Evo Ventilator, GermanyRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00606959054110), received between Oct 6, 2020 and Apr 11, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (10 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 16, 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 · Recall details · 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 · Recall details · 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 · Recall details · 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE FOR THE UNIT TO BE CHECKED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED. DURING THE 'IN PROCESS" EVALUATION, A ¿VENT SERVICE REQUIRED¿ ALARM WAS IDENTIFIED, INDICATING A FAILURE OF THE TOUCHSCREEN DISPLAY. THE DISPLAY PRINTED CIRCUIT ASSEMBLY (PCA) REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. IN ADDITION, THE FRONT PANEL KEYPAD BUTTON WAS DAMAGED, THE KEYPAD DOES NOT FUNCTION PROPERLY, AND THE FRONT PANEL NEEDS TO BE REPLACED. THE INTERNAL BATTERY DOOR WAS FOUND TO BE DAMAGED AND REQUIRES REPLACEMENT. FURTHERMORE, THE BLOWER ASSEMBLY, MACHINE FLOW SENSOR, TUBING FIO2, AND TUBING-BLOWER CHASSIS WERE OBSERVED TO BE CONTAMINATED WITH DUST AND DIRT. AS PART OF FOUR-YEAR PREVENTIVE MAINTENANCE, THE AIR FOAM INLET FILTER, MUFFLER, AND PARTICULATE FILTER NEED TO BE REPLACED. A PREVENTIVE MAINTENANCE (PM) LABEL WILL BE ADDED TO THE UNIT. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852119 ↗
• MalfunctionNov 20, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN "ERROR IN PRESSURE BUILD-UP VALVE FOR SINGLE-HOSE SYSTEM" ON A TRILOGY EVO, GERMANY DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO, GERMANY DEVICE AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR EVT_PRESS_SENSORS_FAILURE WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE'S BLOWER, MACHINE FLOW SENSOR AND ONE OF THE IN-LINE FILTERS ARE CONTAMINATED AND NEEDED TO BE REPLACED. THE AIR FOAM INLET FILTER, MUFFLER AND PARTICULATE FILTER WILL BE REPLACED DUE TO THE 4-YEAR PREVENTIVE MAINTENANCE PROCEDURE. REPLACEMENT OF THE DEVICE'S SYSTEM BOARD ALSO ADDRESSED EVT_OUT_PRESS_RAILED_LOW AND EVT_MON_PRESS_RAILED_LOW ERRORS DISCOVERED IN THE DEVICE'S EVENT LOG. THE DEVICE FAILED A FUNCTIONAL TEST FOR AEV FAILURE WHICH WAS RESOLVED BY RE-SEATING THE TUBING. THE DEVICE PASSED FINAL TESTING. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606450 ↗
• MalfunctionNov 17, 2025Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR THE REPORT OF "DEVICE OUT OF SERVICE". THERE WAS NO HARM OR INJURY REPORTED. ON EVALUATION, VENTILATOR INOPERATIVE ERROR CODE E-264 WAS NOTED IN THE ERROR LOG INDICATING REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY WAS REQUIRED DUE TO THE DATA IN THE ELECTRONICALLY ERASABLE PROGRAMABLE READ-ONLY MEMORY BEING INVALID. AS PART OF MAINTENANCE, THE AIR INLET FOAM FILTER, MUFFLER, AND PARTICULATE FILTER WERE REPLACED TO PREVENT FAILURE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE BLOWER ASSEMBLY REQUIRED REPLACEMENT DUE TO THE NON-CRITICAL ISSUE OF THE MOTOR CONTROLLER PROCEEDING TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE DEVICE PASSED FINAL TESTING AND WAS CONFIRMED TO BE WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576848 ↗
• MalfunctionOct 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED A VENTILATOR SERVICE REQUIRED WHILE USING A TRILOGY EVO DEVICE THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED BECAUSE THE DEVICE DID NOT COME IN WITH THE DETACHABLE BATTERY. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, EVENT BATTERY NOT CHARGING (E-059), WAS OBSERVED IN THE DEVICE'S ERROR LOG FOR THIS DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN USED A "GOLD" BATTERY TO TEST THE DEVICE AND FOUND THE DEVICE WAS WORKING IN PARAMETERS. IN CONCLUSION, THERE WAS NO PART(S) REPLACED AND/OR REPAIR MADE TO THE DEVICE FOR THIS REPORTABLE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR INLET FOAM FILTER NEEDS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. ONE OF THE IN-LINE FILTER NEEDS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418143 ↗
• MalfunctionSep 19, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION AND MOTOR CALIBRATION VERIFICATION: RESET MOTOR CALIBRATION TEST STEPS 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE'S BLOWER CABLE WAS NOT PROPERLY CONNECTED CAUSING A PROPER CONNECTION TO THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD AND MACHINE FLOW SENSOR HAD FAILED. THE THIRD-PARTY SERVICE TECHNICIAN CONFIRMED THAT IT WAS THE REPLACED MACHINE FLOW SENSOR THAT FAILED FOR THESE TEST STEPS; NOT THE ONE THAT HAD CONTAMINATION ON IT. IN CONCLUSION, THE DEVICE'S BLOWER CABLE WAS RE-CONNECTED TO THE SYSTEM PCA BOARD, AND THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUES. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, CONTAMINATION FOUND ON THE BLOWER ASSEMBLY, MACHINE FLOW SENSOR, AND IN-LINE FILTER PROXIMAL WHICH WERE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE FOLLOWING PARTS WERE REPLACED AS PART OF THE FOUR-YEAR PREVENTATIVE MAINTENANCE ON THIS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096833 ↗
• MalfunctionSep 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD-PARTY SERVICE PROVIDER THAT A VENTILATOR INOPERATIVE ERROR CODE WAS FOUND IN A TRILOGY EVO DEVICE'S ERROR LOG DURING PREVENTATIVE MAINTENANCE SERVICING RELATING TO SOFTWARE VERSION MISMATCH. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY EVO VENTILATOR WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND THE SERVICE TECHNICIAN STATES THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE BLOWER ASSEMBLY WAS REPLACED DUE TO A MOTOR CONTROLLER SHUTDOWN ERROR CODE. ALSO, THE MUFFLER ASSEMBLY, BLOWER ASSEMBLY, BELLOW BLOWER, MACHINE FLOW SENSOR, AND IN LINE FILTER WERE REPLACED DUE TO CONTAMINATION. THE AIR FOAM INLET FILTER WAS REPLACED FOR MAINTENANCE. THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057759 ↗
• MalfunctionJun 25, 2025Circuit Failure; Mechanical Problem; Circuit Failure; 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 "VENTILATOR INOPERATIVE " CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S MACHINE FLOW SENSOR AND PCA WAS REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, THE DEVICE'S BLOWER NEED REPLACED DUE AN ERROR CODE. SOFTWARE UPDATE 1.02.01.00 TO 1.02.03.07 TO 1.03.07.00. PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328107 ↗
• MalfunctionMar 7, 2025Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546961 ↗
• MalfunctionJan 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION AND/OR VENT SERVICE REQUIRED CONDITION HAD OCCURRED 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 21286410 ↗
• MalfunctionOct 30, 2024Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A PNEUMATIC TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 20566481 ↗
• MalfunctionOct 24, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S DISPLAY SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS DAMAGED TO THE DISPLAY SCREEN. THE DISPLAY WAS REPLACED ON THE DEVICE. THE FOLLOWING PARTS WERE PROACTIVELY REPLACED ON THE DEVICE: MUFFLER, BLOWER, FLOW SENSOR, BELLOW, IN-LINE FILTER, AND VANITY COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524180 ↗
• MalfunctionJan 2, 2024Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO DELIVER THE REQUIRED PRESSURE AND VENTILATION WAS INSUFFICIENT. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE SPECIFIED. 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 18425279 ↗
• MalfunctionAug 9, 2023Battery Problem; Battery 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 EVALUATION IS STILL 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 17491194 ↗
• MalfunctionAug 7, 2023Mechanical 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, IT WAS OBSERVED THAT THE DEVICE WAS MALFUNCTIONING. THE DEVICE EVALUATION IS STILL 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 17471147 ↗
• MalfunctionJul 18, 2023Contamination; Mechanical Problem; Contamination; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR HAD FAILED TO OPERATE. 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 17343732 ↗
• MalfunctionJun 15, 2023Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 MACHINE FLOW SENSOR AND SYSTEM BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138732 ↗
• MalfunctionNov 16, 2022Tidal Volume Fluctuations; Tidal Volume Fluctuations

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT DELIVERING THE SET VOLUME. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806383 ↗
• MalfunctionNov 16, 2022Tidal Volume Fluctuations; Tidal Volume Fluctuations

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT DELIVERING THE SET VOLUME. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806304 ↗
• MalfunctionOct 19, 2022Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15630920 ↗
• MalfunctionAug 11, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208265 ↗
• MalfunctionJun 27, 2022Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT POWER ON PROPERLY. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830804 ↗
• MalfunctionFeb 8, 2022Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479857 ↗
• MalfunctionFeb 1, 2022Mechanical Problem; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416219 ↗
• MalfunctionJan 31, 2022Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392843 ↗
• MalfunctionSep 8, 2021Mechanical Problem; Mechanical 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 12439774 ↗