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

Model Number	IT2110X21B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator was returned to a third-party service center for evaluation.There was no patient involvement, and no harm or injury reported.On evaluation, a critical event code that indicates the power vbus dropped was recorded in the event log; the system printed circuit board assembly was replaced.Preventative maintenance was completed.Cosmetic damage was reported and components replaced.The device passed final testing and was returned to the customer.Additional findings not related to the malfunction/issue: a non-critical event code was noted in the event log indicating replacement of the machine flow was sensor was required; the machine flow sensor was replaced.
Additional Manufacturer Narrative
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.The reported failure of the trilogy evo v_bus dropping below 8,000v 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.

• Brand Name: Trilogy
• 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: 50951504
• Report Number: 2518422-2026-046686
• Device Sequence Number: 10429733
• Product Code: CBK
• UDI-Device Identifier: 00606959055421
• UDI-Public: (01)00606959055421
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: IT2110X21B
• Device Catalogue Number: IT2110X21B
• 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: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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