MAUDE Adverse Event Report: Respironics, Inc. Trilogy Evo; Ventilator, Continuous, Facility Use

Model Number	DS2110X11B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Recalibrate (1517); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo ventilator was returned to a third-party service center for service due to fsn 2024-cc_src_013.During the evaluation the device failed testing for flow verification: positive flow: measured tidal volume and flow verification: negative flow: measured tidal volume.However, the device passed the pneumatic test.The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the failed test steps, but it does confirm that the device was corrected.The device was corrected, retested and passed the final test.
Additional Manufacturer Narrative
The reported failure of flow verification: positive flow: measured tidal volume and flow verification: negative flow: measured tidal volume 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.Dhr review was performed for the complaint device serial number, (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.

• 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 ; +1(724)733-0200
• MDR Report Key: 50943602
• Report Number: 2518422-2026-046629
• Device Sequence Number: 21445592
• Product Code: CBK
• UDI-Device Identifier: 00606959051942
• UDI-Public: (01)00606959051942
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2020
• 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