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

Model Number	IT2110X21B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a ventilator inoperative condition occurred.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the evaluation of the device at the third-party service center, a ventilator inoperative error code related to the machine flow sensor was observed.Evt_mach_flow_drift_high means the machine flow sensor drifted above the specification (>0.2lpm).The machine flow sensor needs replaced to address the issue.Additionally, separate from the ventilator inoperative reportable error code, an error code related to the motor was observed.Evt_mcl_foc_shutdown means the motor controller has proceeded to the shutdown state due to an error with the motor.The blower assembly needs replaced to address the issue.Also separate from the ventilator inoperative error code, an error code related to sensor offset was observed.Evt_drift_debug means the sensor offset during drift calculation is too high.The system board needs replaced to address the issue.

• Brand Name: TRILOGY EVO ITALY
• 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: 23467074
• Report Number: 2518422-2025-111587
• Device Sequence Number: 15935612
• Product Code: CBK
• UDI-Device Identifier: 00606959055421
• UDI-Public: (01)00606959055421
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/15/2025

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
• Device Model Number: IT2110X21B
• Device Catalogue Number: IT2110X21B
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2019
• 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