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	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy ev0 ventilator inoperative condition occurred.There was no harm or injury reported.The device has not yet been returned to the manufacturer.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 trilogy evo ventilator was returned to a third-party service center for evaluation.On evaluation, it was determined that the motor blower and printed circuit assembly board were faulty.The device error log contained record of a ventilator inoperative error code.The ventilator inoperative condition indicated the machine flow sensor drift was above specification (>0.21pm).It was reported that the system printed circuit assembly board required replacement to address this issue.Additional findings not related to the malfunction/issue include the following: the blower assembly, seals, chassis plate and mounts required replacement due to the motor controller having proceeded to the shutdown state due to an error with the motor.Maintenance activities required included replacement of the muffler assembly, tubing system printed circuit assembly, fio2 tubing and low flow o2 tubing for saline contamination, air inlet foam filter replacement.The device was returned to the customer in a "non-functional condition" without being repaired due to the customer not approving the repairs.However, the trilogy inlet air path foam and pollen filter replacements were made with the scope of fco 2021-06-a.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20621599
• Report Number: 2518422-2024-103376
• Device Sequence Number: 12601044
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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
• Operator of Device: Other
• Device Model Number: CA2110X12B
• Device Catalogue Number: CA2110X12B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2021
• 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