MAUDE Adverse Event Report: Respironics, Inc. Trilogy Evo, Japan; Ventilator, Continuous, Facility Use

Model Number	JP2110X16B
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Circuit Failure (1089); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo ventilator was returned to the manufacturer service center for preventative maintenance.The device was not in use on a patient at the time of the occurrence.During the evaluation the ac power was not recognized therefore the power supply was replaced to resolve the issue.During the final test thermal damage was observed on the ac power cord therefore, the system board was replaced to address the issue.Additionally, during the evaluation the device failed a fio2 sensor receptacle verification test step during testing unrelated to the identified malfunction, therefore, the inline proximal filter was replaced to address the issue.Periodic maintenance 2 was performed.The following parts were replaced to prevent failure: air inlet foam filter muffler assembly and particulate filter.The technician performed final test, battery check, valve check, run in tests and cleaning then confirmed the unit operated properly.The software version was upgraded from 1.06.10.00 to 1.06.15.00.
Additional Manufacturer Narrative
Dhr review was performed for the complaint device sn.Review confirms that the device met the final acceptance criteria and was released for final distribution.The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.Complaints for this failure were reviewed to assess for the observed probability levels and compare 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.

• Brand Name: Trilogy Evo, Japan
• 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 ; +1(724)733-0200
• MDR Report Key: 50569638
• Report Number: 2518422-2026-044539
• Device Sequence Number: 21459585
• Product Code: CBK
• UDI-Device Identifier: 00606959051973
• UDI-Public: (01)00606959051973
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/02/2026

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: JP2110X16B
• Device Catalogue Number: JP2110X16B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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