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

Model Number	1040004TP
Medical Device Problem Codes	Circuit Failure (1089); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was alarming for a service required alarm condition.There was no harm or injury reported.During the evaluation the device's oxygen blending module board needed replaced due to an issue with the oxygen blending module o2 sensor was found in the ventilator's downloaded error log.This issue was not reported as the o2 sensor monitors the oxygen level and does not affect therapy.Additional testing was performed and the device failed positive and negative flow verification test steps.The device's sensor board needs to be replaced to address the issue.The blower motor needs replaced to address noise and a life related smell.The keypad needs replaced due to the surface peeling.The customer cancelled the repair and the device was returned unrepaired.

• 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: 24004301
• Report Number: 2518422-2026-001095
• Device Sequence Number: 21387996
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 03/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2016
• 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