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

Model Number	R1054655TP
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a check circuit error code was found during preventative maintenance on a trilogy 100 device.The device was not in use on a patient at the time of the occurrence.The trilogy 100 device was evaluated at the manufacturer service center.During the evaluation it was noted that the error code, check circuit (e-0291) was observed in the device's error log.The manufacturer service technician further evaluated and determined the error code was generated due to the sensor printed circuit assembly (pca) board.In conclusion, the device's sensor pca board was replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the pollen filter was replaced for preventative maintenance unrelated to the reportable issue.

• 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: 23363568
• Report Number: 2518422-2025-111255
• Device Sequence Number: 9090692
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: R1054655TP
• Device Catalogue Number: R1054655TP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2017
• 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