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

Model Number	BL2110X15B
Medical Device Problem Codes	Contamination (1120); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a third-party service provider that a ventilator inoperative error had occurred on trilogy evo device.There was no serious patient harm or injury that occurred or was reported.The device was sent to a third-party service center for evaluation.The device investigation has yet not begun.A final report will be filed once the investigation has been completed.
Additional Manufacturer Narrative
The manufacturer received information from a third-party service provider that a ventilator inoperative error had occurred on trilogy evo device.There was no serious patient harm or injury that occurred or was reported.The trilogy evo device was returned to the third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the error code, pressure sensor mismatch (e-0384), was observed in the device's error log.The third-party service technician further evaluated and found contamination to the blower, machine flow sensor, and one of the inline proximal filters had caused the issue to occur on the device.In conclusion, the device's blower, machine flow sensor, and inline proximal filter were replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the universal serial bus stick had caused another device error code, software upgrade failure (e-0317), to occur due to a defective software file on the usb stick.This was unrelated to the reported issue.The muffler assembly, particulate filter, air inlet foam filter, and maintenance label were replaced for preventative maintenance unrelated to the to the reported issue.The device 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: 23031146
• Report Number: 2518422-2025-110007
• Device Sequence Number: 21136489
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: BL2110X15B
• Device Catalogue Number: BL2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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