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

Model Number	1040000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy 202 ventilator was returned to the third-party service center for completion of device evaluation.On device evaluation, error code e-344 was noted in the device error log indicating an oxygen blending module accuracy issue.This is potentially a failure of the oxygen blending module, which may impact therapy (delivery of oxygen).The oxygen blending module printed circuit board assembly was replaced to address this issue.The device passed evaluation and repair.Additional findings not related to the malfunction/issue: rubber feet were damaged and one was missing and required replacement.The front enclosure was damaged and required replacement.The handle o-rings were damaged and required replacement.Components were replaced due to preventative maintenance schedule.The machine flow sensor was contaminated.
Additional Manufacturer Narrative
The reported failure of trilogy 202 ventilator oxygen blending module failure 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.
Additional Manufacturer Narrative
Correction to previously reported device evaluation detail.No parts were replaced during the device evaluation; the device was scrapped as per customer request.

• 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 ; 7247330200
• MDR Report Key: 24799840
• Report Number: 2518422-2026-010491
• Device Sequence Number: 18526100
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K093905
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2016
• 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