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

Model Number	BL2110X15B
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	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging ventilator inoperative error codes occurred.There was no serious patient harm or injury that occurred or was reported.Evt_tpy_held_in_bm means therapy cpu is still running in boot monitor software.Evt_power_vbus_dropped means v_bus dropped below 8.000v.Additionally, not related to the reportable ventilator inoperative error codes, an error code related to the air filter and an error code related to the calibration data table occurred.Evt_inlet_filter_blk means the air filter on the blower intake is clogged.Evt_cal_data means erase or write a calibration data table.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging ventilator inoperative error codes occurred.There was no serious patient harm or injury that occurred or was reported.Evt_tpy_held_in_bm means therapy cpu is still running in boot monitor software.Evt_power_vbus_dropped means v_bus dropped below 8.000v.Additionally, not related to the reportable ventilator inoperative error codes, an error code related to the air filter and an error code related to the calibration data table occurred.Evt_inlet_filter_blk means the air filter on the blower intake is clogged.Evt_cal_data means erase or write a calibration data table.During the evaluation of the device at the third-party service center, the device passed the pre-test but it was determined that replacement of the system board was required to address the issue related to the evt_tpy_held_in_bm error.The device evaluation did not identify any specific component malfunction that would need to be replaced to resolve the issue related to the evt_power_vbus_dropped error.The device evaluation did not identify any specific component malfunction that would need to be replaced to resolve the additionally reported non-ventilator inoperative error codes, but the air foam inlet filter, particulate filter and muffler will be replaced as they would be during preventive maintenance.

• Brand Name: TRILOGY EVO BENELUX
• 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: 23300843
• Report Number: 2518422-2025-111031
• Device Sequence Number: 9952925
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: BL2110X15B
• Device Catalogue Number: BL2110X15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2021
• 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