MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR, JAPAN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1054655
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	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information of an inquiry to confirm the operation of pressurization to the exhalation valve and verify the tidal volume in the volume-controlled mode for a trilogy100 ventilator, japan device.There was no allegation of patient harm.The device was not reported to be in patient use.The trilogy 100 device failed at negative flow verification test step during evaluation at the manufacturer's service center.The device's sensor board was replaced to address the issue.Additionally, a periodic maintenance 1 was performed.The device's pollen filter was replaced as regulated by maintenance procedure to prevent failure.The service technician performed repair test, alarm check, battery check, run in tests and cleaning then confirmed the unit operated properly.The software version was checked.(14.1.03).The measured tidal volume was 516 ml when the setting was 500 ml with cv mode, active pap< >, < > breath rate: 12 bpm< >, < > inspiratory time: 1.0 second>, < > flow pattern: square>, < > peep: 0hpa, deep breath: off.

• Brand Name: TRILOGY100 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: 23638927
• Report Number: 2518422-2025-112045
• Device Sequence Number: 9785665
• Product Code: CBK
• UDI-Device Identifier: 00606959025387
• UDI-Public: (01)00606959025387
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: 1054655
• Device Catalogue Number: 1054655
• Device Lot Number: 170829
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2017
• 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