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

Model Number	R1040004TP
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator service required error code was found during preventative maintenance on a trilogy o2 device.The device was not in use on a patient at the time of the occurrence.The trilogy o2 device was being evaluated at the manufacturer service center.During the evaluation it was noted that an error code, oxygen blending module (obm) accuracy urgency service (e-0344), was observed on the device's error log.The manufacturer service technician further evaluated and determined the oxygen sensor had failed.The manufacturer service technician replaced the obm printed circuit assembly (pca) since it installs the oxygen sensor.This addressed the reportable issue.The manufacturer service technician tested the device, and it failed on the zero flow verify test step.The manufacturer service technician re-evaluated the device and determined the test step failed due to the sensor pca.The sensor pca was replaced to address this reportable issue.The root cause is confirmed at this time.Additionally, during the service of the device, the trilogy o2 pm, capacitor, battery fan exhaust fan assembly, stirring fan, and forty-three micron filer was replaced for service, which was unrelated to the reportable issue.The front enclosure needs replaced due to physical damage unrelated to the reportable issue.

• Brand Name: TRILOGY O2 VENTILATOR, JAPAN
• 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: 24248583
• Report Number: 2518422-2026-003902
• Device Sequence Number: 12843682
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: R1040004TP
• Device Catalogue Number: R1040004TP
• Device Lot Number: 171103
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2017
• 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