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

Model Number	CA2110X12B
Medical Device Problem Codes	Failure to Calibrate (2440); Device Sensing Problem (2917)
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 the active exhalation verification test step had failed during preventative maintenance on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was evaluated at the third-party service center.During the evaluation it was noted that the devices proportional valve and three-way (3-way) solenoid valve had caused the active exhalation verification test step to fail on the device.In conclusion, the device's proportional valve and 3-way solenoid valve needs replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the front panel needs replaced for physical damage unrelated to the reportable issue.The particulate filter, muffler assembly, and air inlet foam filter needs replaced for preventative maintenance unrelated to the reported issue.The vanity cover, blower bellows seal, blower mount, internal battery door, base assembly, fan retainer, system printed circuit assembly tubing, blower chassis, fio2 tubing, and low flow tubing needs replaced for contamination unrelated to the reportable issue.Per the customer's request, the device was returned unrepaired.

• 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: 23295059
• Report Number: 2518422-2025-111012
• Device Sequence Number: 4862023
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2020
• 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