Trilogy Evo DS2100X11BRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00606959051997), received between Dec 29, 2021 and May 1, 2026 — classified as 2 deaths, 13 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (8 reports).

6 FDA recall records name this device's identifier, 6 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-0290-2025 · 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-1502-2024 · 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-1650-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Mar 1, 2023Open, Classified

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

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

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH REPORT (MW5186409) INDICATING THAT A HOME HEALTH NURSE CONTACTED THE DURABLE MEDICAL EQUIPMENT (DME) PROVIDER TO REPORT AN ISSUE WITH A TRILOGY EVO VENTILATOR. THE DEVICE REPORTEDLY DISPLAYED A ¿VENT INOPERABLE¿ MESSAGE AND THE SCREEN BECAME UNRESPONSIVE. AT THE TIME OF THE EVENT, THE PATIENT WAS NOT CONNECTED TO THE VENTILATOR, AS THE DEVICE IS USED ONLY DURING NIGHTTIME HOURS. NO PATIENT IMPACT OR INJURY WAS REPORTED. THE VENTILATOR WAS REPLACED AND RETURNED TO THE DME PROVIDER¿S BIOMEDICAL DEPARTMENT FOR FURTHER EVALUATION. THE DEVICE SERIAL NUMBER WAS NOT PROVIDED IN THE REPORT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056399 ↗
• MalfunctionOct 20, 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 CONDITION OCCURRED ON A TRILOGY EVO DEVICE. 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 23341446 ↗
• MalfunctionFeb 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT PUT THE UNIT ON STANDBY FOR RESTROOM BREAK BUT UPON RETURNING THE SCREEN WAS FROZEN AND THEY WERE UNABLE TO DO ANYTHING. THERE WAS NO HARM OR INJURY REPORTED. THE SCREEN LOCK WAS CHECKED. TROUBLESHOOTING PROVIDED ON HOW TO DO A HARD SHUT DOWN AND POSSIBLY REMOVING THE SETTINGS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432479 ↗
• DeathFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT HAD AN EVENT. ADDITIONAL INFORMATION REQUESTED AND REPORTER PROVIDED INFORMATION ON 28-JAN-2025, VIA EMAIL, THAT PATIENT WAS DECEASED. THE REPORTED EVENT PROVIDED IN GOOD FAITH EFFORTS STATING THE PATIENT WAS DECEASED MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USER ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED. BASED ON AVAILABLE INFORMATION AT THIS TIME, THE ALLEGED HARM DEATH IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 21413667 ↗
• MalfunctionSep 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED ON SEVERAL UNITS. THERE WAS NO HARM OR INJURY REPORTED. THE REPORTER STATED THERE ARE SEVERAL UNITS GETTING VENTILATOR INOPERATIVE OR SERVICE REQUIRED ALARMS. THE REPORTER DID NOT HAVE THE SERIAL NUMBERS OF THE INVOLVED UNITS AT THE TIME OF THE REPORT. THE UNITS WERE ALSO REPORTED TO 1.05.06 VERSION SOFTWARE. THE DEVICES HAVE 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 20279457 ↗
• MalfunctionJun 3, 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 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 19447897 ↗
• DeathApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT PASSED AWAY WHILE ON THE DEVICE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. 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 19097614 ↗
• MalfunctionMar 31, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009304 ↗
• MalfunctionDec 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318458 ↗
• MalfunctionJun 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S SCREEN WAS FROZEN. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071216 ↗
• MalfunctionFeb 10, 2023Failure to Charge; Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR ALARMED FOR INTERNAL BATTERY ISSUE. THERE WAS NO HARM OR INJURY REPORTED. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353500 ↗
• MalfunctionOct 18, 2022Electrical /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 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 15627274 ↗
• MalfunctionAug 30, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S TOUCHSCREEN WAS UNRESPONSIVE. THE DEVICE WAS NOT IN PATIENT USE. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322860 ↗
• MalfunctionJan 13, 2022No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS BLANK. THE DEVICE WAS NOT IN PATIENT USE. 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 13251738 ↗
• MalfunctionDec 29, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13108156 ↗