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

Model Number	CA2110X12B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy evo ventilator failed and was continually alarming.The customer was unable to silence the device.There was no harm or injury reported.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy evo ventilator failed and was continually alarming.The customer was unable to silence the device.There was no harm or injury reported.The device was returned to a third-party service center for evaluation.The customer's complaint was not confirmed.The device was found to perform as designed.No malfunctions were noted.Preventive maintenance was required.During the evaluation the device was found to need cleaning and some parts replaced due to contamination.The following parts were replaced due to contamination: particulate filter, blower bellows seal, blower mount, cooling fan assembly, fan retainer, machine flow sensor, muffler assembly, system board tubing, blower chassis tubing, fio2 tubing and low o2 flow tubing.The device's internal battery door was replaced due to physical damage and the filter cover was replaced due to it being missing.The device's air inlet foam filter was replaced per preventive maintenance protocol.The device was cleaned and tested and passed all final testing.

• 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: 21458090
• Report Number: 2518422-2025-102327
• Device Sequence Number: 7591940
• Product Code: CBK
• UDI-Device Identifier: 00606959052307
• UDI-Public: (01)00606959052307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/31/2025

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: CA2110X12B
• Device Catalogue Number: CA2110X12B
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown