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

Model Number	DE2110X13B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an "error in pressure build-up valve for single-hose system" on a trilogy evo, germany device.There was no harm or injury reported.The device was not in patient use.During the evaluation of the trilogy evo, germany device at the third-party service center, a ventilator inoperative error evt_press_sensors_failure was discovered in the device's event log.The device's system board was replaced to address the issue.Additionally, the device's blower, machine flow sensor and one of the in-line filters are contaminated and needed to be replaced.The air foam inlet filter, muffler and particulate filter will be replaced due to the 4-year preventive maintenance procedure.Replacement of the device's system board also addressed evt_out_press_railed_low and evt_mon_press_railed_low errors discovered in the device's event log.The device failed a functional test for aev failure which was resolved by re-seating the tubing.The device passed final testing.This device has been serviced, inspected, tested, and met acceptance criteria in accordance with all of the applicable customer requirements.

• Brand Name: TRILOGY EVO, GERMANY
• 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: 23606450
• Report Number: 2518422-2025-111959
• Device Sequence Number: 9444387
• Product Code: CBK
• UDI-Device Identifier: 00606959054110
• UDI-Public: (01)00606959054110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: DE2110X13B
• Device Catalogue Number: DE2110X13B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2020
• 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