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

Model Number	EU2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a third-party distributor that a trilogy evo ventilator is not operative.There was no serious patient harm or injury that occurred or was reported.The device has not yet been returned for evaluation.Good faith efforts are actively being made to have the device returned for evaluation.If the device is returned and evaluated, a follow-up report will be submitted with the evaluation results.
Additional Manufacturer Narrative
The manufacturer received information from a third-party distributor that a trilogy evo ventilator is not operative.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 an error code, internal battery not detected event (e-046) was found on the device's error log.During the evaluation, the third-party service technician did not provide any findings on the cause of the ventilator not operative for this device.In addition, the system leak verification test step had failed during testing of the device.The third-party service technician evaluated and determined the tubing had caused the system leak test to fail on the device.The third-party service technician reseated the tubing to address this issue.Additionally, during the service of the device, the air foam inlet filter, particulate filter, and muffler were replaced for preventative maintenance unrelated to the reportable issue.The machine flow sensor was replaced for contamination unrelated to the reportable issue.The device passed all final testing.

• Brand Name: TRILOGY
• 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: 22841022
• Report Number: 2518422-2025-109223
• Device Sequence Number: 15861821
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/11/2025

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2019
• 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