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

Model Number	FR2110X14B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilation inoperative error code was observed on the device's error log during a four-year preventative maintenance service was being performed on the trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was having a four-year preventative maintenance service being performed by the third-party service center when the reported issue had occurred on the device.During the evaluation, it was noted that a ventilator inoperative error code, therapy held in boot monitor, was observed on the device's error log for this device.The third-party service technician evaluated and determined the system printed circuit assembly (pca) had caused the error code to occur on the device.The third-party service technician observed another error code, internal battery not detected, in the device's error log.The third-party service technician evaluated for this error code and determined that the system pca had caused this to occur on the device.In conclusion, the system pca needs replaced to address this issue.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 supplemental report will be completed.Additionally, during the service of the device, the blower assembly, machine flow sensor, and in-lint proximal filter were replaced for contamination unrelated to the reportable issue.The internal battery and system pca need replace for an error code, internal battery depleted and soft power fail, that were observed on the device's error log, which was unrelated to the reportable issue.The system pca needs replaced related to an error code, internal battery in use, that was observed in the device's error log, which was unrelated to the reportable issue.The detachable battery needs replaced related to an error code, detachable battery in use disconnected, observed in the error log.This was unrelated to the reportable issue.The air foam filter, muffler, and particulate needs replaced for preventative maintenance unrelated to the reportable issue.

• 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: 24590332
• Report Number: 2518422-2026-009464
• Device Sequence Number: 12976948
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: (01)00606959055506
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• 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
• Report Date (Section B): 03/12/2026

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: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2019
• 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