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

Model Number	1040000
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	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator service required alarm had occurred on a trilogy 202 device.The device was not in use on a patient at the time of the occurrence.The trilogy 202 device was evaluated by a third-party service technician, and the customer¿s complaint was confirmed.During the evaluation it was noted that error codes, proximal pressure railed and drift proximal pressure too high, were observed in the device's error log.The third-party service technician evaluated and determined the oxygen blending module (obm) printed circuit assembly (pca) and oxygen (o2) pca had caused these two error codes to occur on the device.In conclusion, the device's obm pca and o2 pca need replacing to address the issue.A quote was provided to the customer for repairs to be made for this issue.No repairs or parts were replaced at this time.The root cause is confirmed at this time.

• 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: 24803327
• Report Number: 2518422-2026-010508
• Device Sequence Number: 10682195
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 1040000
• Device Catalogue Number: 1040000
• Device Lot Number: 151020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2015
• 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