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

Model Number	EE2100X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of active exhalation verification: s (+) p (-): pilot: reading test is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of 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.
Event or Problem Description
The manufacturer received a report that a trilogy evo ventilator was returned for preventive maintenance.No patient harm or injury was reported.The device was evaluated at a third-party service center.The device log files were successfully downloaded and reviewed in full.No critical errors were observed.During functional testing, the device failed the active exhalation verification: s (+) p (-): pilot: reading test.Subsequent evaluation identified an event error indicating that the sensor offset during drift calculation was too high.To address the issue, the system printed circuit assembly (pca) was replaced.As part of the device¿s scheduled four-year preventive maintenance, the air foam filter and particulate filter were also replaced.Following the repair, the device passed all 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: 25216721
• Report Number: 2518422-2026-014660
• Device Sequence Number: 21281463
• Product Code: CBK
• UDI-Device Identifier: 00606959055698
• UDI-Public: (01)00606959055698
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: EE2100X15B
• Device Catalogue Number: EE2100X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown