MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040004TP
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	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for preventive maintenance.There was no harm or injury reported.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, a "service required" alarm indicating an air flow sensor failure occurred was found in the ventilator's downloaded error log.The device's oxygen blending module board was replaced to address the issue.The device was tested and passed all final testing.

• Brand Name: TRILOGY O2
• 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: 24258752
• Report Number: 2518422-2026-004071
• Device Sequence Number: 7975734
• Product Code: CBK
• UDI-Device Identifier: 00606959025394
• UDI-Public: (01)00606959025394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083526
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 1040004TP
• Device Catalogue Number: 1040004TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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