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

Model Number	IN2110X15B
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo device was returned to a third-party service center for service.No medical intervention was specified.The device was not reported to be in clinical use.During the evaluation, the error log was downloaded and reviewed.An e0384 (evt_press_sensor_mismatch) error was identified.The air pathway was inspected for environmental debris and contamination; none was found.The evaluation did not identify a specific cause for the e0384 error.The device subsequently passed performance verification following service.Additionally, the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.Preventive maintenance components, including the particulate filter, inlet foam filter, and muffler, were replaced as part of the four-year service.A missing filter cover was also identified during external inspection and replaced.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
During the evaluation, the error log was downloaded and reviewed.An e0384 (evt_press_sensor_mismatch) error was identified.The air pathway was inspected for environmental debris and contamination; none was found.The evaluation did not identify a specific cause for the e0384 error.The device subsequently passed performance verification following service.Additionally, the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.Preventive maintenance components, including the particulate filter, inlet foam filter, and muffler, were replaced as part of the four-year service.A missing filter cover was also identified during external inspection and replaced.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.Dhr review was performed for the complaint device sn.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: 50948383
• Report Number: 2518422-2026-046663
• Device Sequence Number: 10348756
• Product Code: CBK
• UDI-Device Identifier: 00606959051959
• UDI-Public: (01)00606959051959
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Distributor
• 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
• Device Model Number: IN2110X15B
• Device Catalogue Number: IN2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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