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

Model Number	EU2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from the customer alleging a patient experienced a ventilation inoperative state that had allegedly occurred with the same errors while using a trilogy evo device.The customer alleged that a machine flow drift high, pressure sensor mismatch error codes had occurred on the device along with two other error codes, motor controller force shutdown and drift debug, for this device.There was no allegation of serious or permanent harm or injury.There was no medical intervention specified by the customer.Philips is currently investigating this complaint.The device has been received by the third-party service center and is currently awaiting evaluation.A supplemental report will be submitted as due.
Additional Manufacturer Narrative
The manufacturer received information from the customer alleging a patient experienced a ventilation inoperative state that had allegedly occurred with the same errors while using a trilogy evo device.The customer alleged that a machine flow drift high, pressure sensor mismatch error codes had occurred on the device along with two other error codes, motor controller force shutdown and drift debug, for this device.There was no allegation of serious or permanent harm or injury.There was no medical intervention specified by the customer.The trilogy evo device was returned to the third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the machine flow sensor had caused the machine flow drift high error code to occur on the device.There is no documentation stated on a root cause and/or any component replacement to resolve the pressure sensor mismatch error code.In conclusion, the device's machine flow sensor was replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the blower was replaced to address the motor controller force shutdown error code, which was unrelated to the reportable issue.The system printed circuit assembly (pca) was replaced to address the drift debug error code, which was unrelated to the reportable issue.The air inlet foam filter and particulate filter were replaced for preventative maintenance unrelated to the reportable issue.The device passed all final testing.

• 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: 24448348
• Report Number: 2518422-2026-006535
• Device Sequence Number: 10212625
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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
• Operator of Device: Other
• Device Model Number: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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