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

Model Number	ES2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a blower calibration failure in a trilogy evo iberia device.No harm or injury was reported.The device was not in patient use at the time of the event.The device was returned to a third-party service center; however, the evaluation has not yet begun.A review of the device log identified an evt_mach_flow_drift_high error, which initiated this report.The manufacturer's investigation is ongoing.At this time, the root cause has not been determined.If additional information becomes available, a supplemental report will be submitted.

• Brand Name: TRILOGY EVO, IBERIA
• 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: 25430331
• Report Number: 2518422-2026-019970
• Device Sequence Number: 10359293
• Product Code: CBK
• UDI-Device Identifier: 00606959054080
• UDI-Public: (01)00606959054080
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: ES2110X15B
• Device Catalogue Number: ES2110X15B
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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