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

Model Number	RJP2110X16B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo device had a ventilator service required alarm while in patient use.There is no allegation of serious or permanent harm or injury.The device was returned to the manufacturer for evaluation.During the evaluation, it was noted that error code e385 (evt_mach_flow_drift_vrs) was found in the device log.This error indicates that the flow sensor had experienced drift exceeding specifications.The system printed circuit assembly (pca) that performs flow sensor signal processing and drift determination was replaced to address the issue.Additionally, no dirt was found on the airflow path at that time.Performed final test, battery check, valve check, run in tests and cleaning then confirmed the unit operated properly.Device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined.At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation.
Additional Manufacturer Narrative
The reported failure of evt_mach_flow_drift_vrs 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.Dhr review was performed for the complaint device sn (b)(6).Review confirms that the device met the final acceptance criteria and was released for final distribution.

• 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: 50895939
• Report Number: 2518422-2026-046451
• Device Sequence Number: 6001002
• 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: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: RJP2110X16B
• Device Catalogue Number: RJP2110X16B
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown