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

Model Number	R1040004TP
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator service required alarm had occurred while performing the operational check 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 returned to the manufacturer service center for preventative maintenance when the ventilator service required alarm sounded on the device.During the evaluation it was noted that an error code, oxygen blending module (obm) accuracy urgency service, error code was observed on the device's error log.The service technician further evaluated and determined the air flow sensor located on the obm blender printed circuit assembly (pca) had caused the ventilator service required alarm to occur on the device.In conclusion, the obm blender pca was replaced to address the issue.The root cause is confirmed at this time.

• 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: 25070804
• Report Number: 2518422-2026-011517
• Device Sequence Number: 10747327
• 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): 05/04/2026

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
• Operator of Device: Other
• Device Model Number: R1040004TP
• Device Catalogue Number: R1040004TP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown