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

Model Number	EE2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of internal battery not detected and power_vbus_dropped 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.
Event or Problem Description
The trilogy evo ventilator was returned to the third-party service center due to the allegation of (after the service the device still says ventilator service required).The device was not in use by a patient at the time of the occurrence.During the inprocess evaluation of the device by the third-party service center an error code in relation to internal battery not detected and power vbus dropped were recorded in the device event log.The service technician confirmed that the reported error cods were due to contamination and that no corrective action was required.Additionally, during the service of the device an error code in relation to the internal or detachable li-ion battery is not charging due to a hardware fault greater then 1 minute was observed in the device event log, therefore, the detachable battery needs to be replaced to address the issue.Also error codes in relation to soft power fail, hard power fail were recorded in the device event log.The blower assy, blower bellows seal, machine flow sensor, tubing-blower chassis, tubing-fio2, tubing-low flow o2 and tubing-system board are contaminated with dust and dirt.Preventative maintenance will be performed, and the air foam inlet filter, muffler and particulate filter need to be replaced.The software was upgraded to version 1.06.15.00.Philips is currently investigating this complaint.A supplemental report will be submitted as due.

• 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: 25079212
• Report Number: 2518422-2026-011537
• Device Sequence Number: 16061647
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2021
• 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