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

Model Number	R1054655TPV
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging upper half of the screen became dark during use of a trilogy 100 ventilator.The device was not reported to be in use on a patient at the time of the occurrence.The trilogy 100 ventilator was returned to the manufacturer service center for evaluation, and the customer¿s complaint was not duplicated by operational checking performed, and it was confirmed that the screen display was readable.In addition, the error log was checked, and it was confirmed that no error indicating a device failure had been logged.Based on the situation at the time of the event, it has been determined that a temporary failure occurred in the systems lcd.The repair was canceled, and the device will be scrapped.The faulty lcd will be removed from the device and returned to the manufacturer service center for further investigation of the failure.Confirmed the software version is 14.1.03.If any additional information is received, a follow-up report will be filed.

• 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: 23646833
• Report Number: 2518422-2025-112082
• Device Sequence Number: 4823261
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Other
• Device Model Number: R1054655TPV
• Device Catalogue Number: R1054655TPV
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown