MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ES2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885); Device Sensing Problem (2917); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a rar reading error vti and vte occurred regarding a trilogy evo ventilator.The device was not use on a patient at the time of the occurrence.The trilogy evo ventilator was returned to the third-party service center for evaluation.While reviewing the error log, critical error codes in relation to (soft power failure, the device software has detected a large pressure drop between the monitor and outlet pressure sensors, internal battery depleted and internal battery not detected) was observed.The manufacturer investigation is ongoing.If new information becomes available a supplemental report will be completed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a rar reading error vti and vte occurred regarding a trilogy evo ventilator.The device was not use on a patient at the time of the occurrence.The trilogy evo ventilator was returned to the third-party service center for evaluation.While reviewing the error log, critical error codes in relation to (soft power failure, the device software has detected a large pressure drop between the monitor and outlet pressure sensors, internal battery depleted and internal battery not detected) was observed.The manufacturer investigation is ongoing.If new information becomes available a supplemental report will be completed.New information: the trilogy evo ventilator was returned to the third-party service center for evaluation.While reviewing the error log, error codes in relation to (soft power failure, the device software has detected a large pressure drop between the monitor and outlet pressure sensors, internal battery depleted and internal battery not detected) was observed in the device event log.The technician states the recorded error codes do not require corrective actions.Additionally, the air inlet foam filter and particulate filter were replaced as a part of preventive maintenance.Error codes in relation to erase or write a calibration data table and sensor offset during drift calculation is too high were recorded in the device event log therefore the system board was replaced to address the issues.The machine flow sensor was replaced due to error code e 386.The 2 in-line filter prox was contaminated with dust.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements as defined in the contractual agreement with plexus.The device history record has been reviewed and approved by plexus quality assurance.The device passed all test.Box h was updated.The reported failure of (rar reading error vti and vte) is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.

• Brand Name: TRILOGY EVO
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24647678
• Report Number: 2518422-2026-009809
• Device Sequence Number: 9895320
• Product Code: CBK
• UDI-Device Identifier: 00606959054080
• UDI-Public: (01)00606959054080
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: ES2110X15B
• Device Catalogue Number: ES2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown