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

Model Number	EE2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a red alarm condition involving a trilogy evo ventilator during patient use.No patient harm or injury was reported.During the in process evaluation of the device at a third-party service center, review of the event and error logs identified ventilator inoperative events evt_motor_shutdown and evt_tpy_held_in_bm.Based on these findings, replacement of the system printed circuit assembly (pca) was recommended.Review of the error log also identified an evt_mach_flow_drift_high ventilator inoperative error, indicating that the machine flow sensor had drifted above specification and required replacement.Additional review of the error log identified evt_mcl_foc_shutdown and evt_motor_flux_magnitude_runtime events, resulting in a recommendation to replace the device blower.The air foam inlet filter and particulate filter were identified for replacement in accordance with preventive maintenance requirements.One in-line filter prox was found contaminated with dust and required replacement.At the time of this report, the device was out of warranty and awaiting customer approval for repair.The investigation remains ongoing.No patient harm or injury was reported.If additional information becomes available following completion of the repair that impacts the investigation findings or reportability determination, a supplemental report will be submitted.
Additional Manufacturer Narrative
The reported failure of ventilator inoperative error codes is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.¿review of the dhr for this device, serial number (b)(6), did not find any non-conformances or abnormalities related to the reportable malfunction/ allegation identified in this complaint record during testing of the device prior to distribution.¿.

• Brand Name: TRILOGY EVO, EASTERN EUROPE
• 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: 25546365
• Report Number: 2518422-2026-023565
• Device Sequence Number: 5571632
• Product Code: CBK
• UDI-Device Identifier: 00606959055544
• UDI-Public: (01)00606959055544
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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
• Device Model Number: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2022
• 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