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

Model Number	CA1040000
Medical Device Problem Codes	Circuit Failure (1089); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that an trilogy 202 ventilator was evaluated by the manufacturer's service center for the complaint of an error code.There was no harm or injury reported.Upon inspecting the error logs of the device, urgent code e-344 was discovered, indicating an oxygen blending module pca board failure.In order to address this code, the corresponding board and gasket were replaced, and the repair test was conducted.During the final steps of the repair test, it was discovered that the internal battery was also not properly holding charge.To address this issue, the internal battery was replaced, and the test was restarted which then resulted in a pass.The device passed final testing after repair and was determined to operate properly.The system meets the specification for the performed service and is returned to use.
Additional Manufacturer Narrative
Correction to initial report: on quality review of this complaint record, it has been determined that the manufacturer's awareness date of the event was incorrectly reported.This follow-up report corrects the awareness date to the appropriate date of 20 november 2025 with an adjusted report due date of 20 december 2025.The affected fields have been updated to the correct information with this report.

• 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: 23726822
• Report Number: 2518422-2025-112349
• Device Sequence Number: 16101062
• Product Code: CBK
• UDI-Device Identifier: 00606959022799
• UDI-Public: (01)00606959022799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: CA1040000
• Device Catalogue Number: CA1040000
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2020
• 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