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

Model Number	1054655
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an alarm occurred while the trilogy 100, japan device was in patient use.It was reported that there are times during use of the device when low inspiratory pressure alarm occurs frequently.There was no allegation of harm or injury reported.During the evaluation of the trilogy 100, japan device at the manufacturer's service center, the customer's allegation was confirmed.When a test was performed for verification, the repair test resulted in fail, which revealed that a failure occurred in the part to control the exhalation valve.The technician recommended replacing the device's active exhalation control module to address the issue.The repair was canceled due to the lease term of the device being up.The device will be scrapped.Additionally, confirmed the software version is 14.1.03.

• 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: 23792341
• Report Number: 2518422-2025-112614
• Device Sequence Number: 12190719
• 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): 12/12/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2018
• 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