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

Model Number	1054655TP
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	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging when setting the tidal volume (vti) at five hundred milliliter (500 ml) that the airflow rate was measured at four hundred twenty-five ml (425 ml) had occurred 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 returned to the manufacturer service center for evaluation.During the evaluation it was noted when measured the ventilation volume using the set value that was used, the vti was at four hundred seventy-five ml (475 ml); which was in the allowable range, and it was not confirmed that the value was deviated from the allowable range.The manufacturer's service technician stated that the "trilogy's tidal volume control accuracy is fifteen ml (15 ml) or ten percent (10%) of the set value.The manufacturer's service technician evaluated the device's error log, and there were no alarms indicating an abnormality of the device had occurred.The manufacturer's service technician performed the flow verification test steps on the device.The flow verification test steps had failed, which were the item for ventilation volume.The manufacturer's service technician evaluated and determined the sensor printed circuit assembly (pca) board had caused these flow test steps to fail on the device.In conclusion, the device's sensor pca board was replaced to address the issue.The root cause is confirmed at this time.

• 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: 23418405
• Report Number: 2518422-2025-111437
• Device Sequence Number: 18379005
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 1054655TP
• Device Catalogue Number: 1054655TP
• Device Lot Number: 180927
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2018
• 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