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

Model Number	BL2110X15B
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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilation inoperative alarm had occurred on a trilogy evo device.The customer stated that error code, machine flow drift high (e-0155), was observed on the device's error log.The device was not in use on a patient at the time of the occurrence.Additionally, the customer mentioned that two additional nonreportable error codes, event drift debug (e-0330) and motor controller force shutdown(e-0144), were observed on the device's error log for this device.Philips is currently investigating this complaint; however, the device examination has not begun because the device has not yet been returned to the manufacturer for investigation.As part of the complaint handling process, the manufacturer will attempt to retrieve the device for investigation.
Additional Manufacturer Narrative
The manufacturer received information alleging a ventilation inoperative alarm had occurred on a trilogy evo device.The customer stated that error code, machine flow drift high (e-0155), was observed on the device's error log.The device was not in use on a patient at the time of the occurrence.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 devices machine flow sensor had caused the ventilation inoperative alarm to occurred on the device.In conclusion, the device's machine flow sensor was replaced to address the issue.The root cause is confirmed at this time.Additionally, the customer mentioned that two additional nonreportable error codes, event drift debug (e-0330) and motor controller force shutdown(e-0144), were observed on the device's error log for this device.The third-party service technician evaluated and determined the system printed circuit assembly (pca) was replacing to address this issue.This was unrelated to the reportable issue.One of the in-line filter was replaced for contamination unrelated to the reportable issue.The air inlet foam filter was replaced for preventative maintenance unrelated to the reportable issue.

• Brand Name: TRILOGY EVO
• 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: 24075257
• Report Number: 2518422-2026-002384
• Device Sequence Number: 10226864
• Product Code: CBK
• UDI-Device Identifier: 00606959055520
• UDI-Public: (01)00606959055520
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/26/2026

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: BL2110X15B
• Device Catalogue Number: BL2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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