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

Model Number	1040000
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	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was previously reported: the manufacturer received information alleging a trilogy 202 ventilator requires maintenance service.There was no patient involvement, and no harm or injury reported.The device was returned to a third-party service center for evaluation with the following findings: a critical ventilator service required error code e-147 was noted in the device's download error log indicating the proximal pressure sensor has drifted so much that the device cannot adjust for it.The device was confirmed to have been powered on at the time this event occurred.Evaluation determined the sensor printed circuit board assembly required replacement to address this issue.Additional findings not related to the malfunction/issue: the rubber feet and the whisper cap were missing and required replacement.The warning label and serial number label had scratches on them and required replacement, the front enclosure required replacement with the new version so the safety data (sd) card could no longer have space to slide around inside the device.The porting block was deformed and required replacement.The oxygen blending module gasket was noted to be contaminated and required replacement.The pollen filter needed to be replaced due to preventative maintenance.The device failed functional testing due to the calibration table requiring recalibration.After recalibration was completed, the device passed functional testing.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.Additional clarifications and coding corrections are made with this follow up report.The manufacturer investigated the returned device by reviewing the customer complaint, device history, usage data, error logs, and by performing physical inspection, calibration review, and functional testing.The reported ¿maintenance required¿ alert was reproducible and associated with error code e147 (sensor drift).Component wear and contamination consistent with extended use were identified, including a contaminated obm gasket and a pollen filter exceeding preventive maintenance intervals.No manufacturing defect, design issue, software malfunction, misuse, or abnormal operation was identified.Corrective actions included replacement of the sensor board and worn components and recalibration of the device, after which all run-in, functional, and electrical safety tests passed.The investigation concluded that the event was caused by sensor drift due to normal wear and exceeded preventive maintenance intervals, with no serious injury or deterioration in health reported.The coding grid has been updated accordingly.
Event or Problem Description
The manufacturer received information alleging a trilogy 202 ventilator requires maintenance service.There was no patient involvement, and no harm or injury reported.The device was returned to a third-party service center for evaluation with the following findings: a critical ventilator service required error code e-147 was noted in the device's download error log indicating the proximal pressure sensor has drifted so much that the device cannot adjust for it.The device was confirmed to have been powered on at the time this event occurred.Evaluation determined the sensor printed circuit board assembly required replacement to address this issue.Additional findings not related to the malfunction/issue: the rubber feet and the whisper cap were missing and required replacement.The warning label and serial number label had scratches on them and required replacement, the front enclosure required replacement with the new version so the safety data (sd) card could no longer have space to slide around inside the device.The porting block was deformed and required replacement.The oxygen blending module gasket was noted to be contaminated and required replacement.The pollen filter needed to be replaced due to preventative maintenance.The device failed functional testing due to the calibration table requiring recalibration.After recalibration was completed, the device passed functional testing.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.

• Brand Name: TRILOGY
• 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: 24145604
• Report Number: 2518422-2026-003128
• Device Sequence Number: 8887785
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: (01)00606959022706
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2026

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: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2011
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown