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

Model Number	BL2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy evo device failed the pv test fail p.Prox test.There was no allegation of patient harm.The device was not reported to be in patient use.The device has yet to be returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the service center's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information received alleging a trilogy evo device failed the pv test fail p.Prox test.There was no allegation of patient harm.The device was not reported to be in patient use.During the evaluation of the device at the third-party service center, a ventilator inoperative error was discovered in the device's event log.The technician recommended replacing the device's system board to address the issue.Additionally, the device's machine flow sensor and in-line filter prox are contaminated, and the vo main housing is damaged and will need to be replaced.The device's muffler assembly, air foam inlet filter and particulate filter will be replaced due to the 4 year preventive maintenance requirements.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• 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: 22676769
• Report Number: 2518422-2025-108485
• Device Sequence Number: 12984818
• Product Code: CBK
• UDI-Device Identifier: 00606959055520
• UDI-Public: (01)00606959055520
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/09/2025

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: BL2110X15B
• Device Catalogue Number: BL2110X15B
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown