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

Model Number	FR2110X14B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of (machine flow sensor railed to maximum negative value, machine flow sensor communication ceased, and the sensor is stuck at same value, soft_power_fail and the device software has detected a large pressure drop between the monitor and outlet pressure sensors (i.E.Across the machine flow sensor) is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary 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.Review of the dhr for this device, serial number (b)(6), did not find any non-conformances or abnormalities related to the reportable malfunction/ allegation identified in this complaint record during testing of the device prior to distribution.¿.
Event or Problem Description
The trilogy evo ventilator was returned to the third-party service center for preventative maintenance.The device was not reported to be in use on a patient at the time of the occurrence.During the evaluation of the device a ventilator inoperative condition was observed in the device event log.Error codes in relation to (machine flow sensor railed to maximum negative value, machine flow sensor communication ceased, and the sensor is stuck at same value, soft_power_fail and the device software has detected a large pressure drop between the monitor and outlet pressure sensors (i.E.Across the machine flow sensor) was observed.In conclusion the machine flow sensor was replaced to address the issues.Additionally, during the service of the device, the system board and blower were replaced to address error codes in relation to mcl_foc_shutdown and ambient light unrelated to the reportable malfunction/issue.In addition, components were replaced as part of maintenance of the device or contamination.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.

• 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: 25638926
• Report Number: 2518422-2026-026570
• Device Sequence Number: 9343996
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: (01)00606959055506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/26/2026

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: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2021
• 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