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); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of the internal battery is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.
Event or Problem Description
A trilogy evo, iberia ventilator was returned to a third-party service center for service, at which time it was reported that the service kit was missing.The issue with the service kit was resolved.There was no allegation of device malfunction.The device was not reported to be in patient use.During the evaluation of the trilogy evo, iberia device at a third-party service center, an evt_battery_not_charging_fault error was identified in the device's event log.This error indicates that the internal or detachable li-ion battery was not charging due to a hardware fault for a duration of greater than or equal to one minute.The service technician recommended replacement of the device's internal battery to address this issue.Additional evaluation determined that the device's system board requires replacement due to the presence of evt_sw_upgrade_failure and evt_drift_debug error codes.Other non-actionable errors found in the event log were attributed to contamination.The device's tubing-fio2, in-line filter, and machine flow sensor were found to be contaminated with dirt and will require replacement.As part of the 4-year preventive maintenance procedure, the air foam inlet filter, muffler, and particulate filter will also be replaced, and a pm label will be added to the unit.The device is out of warranty and is currently awaiting customer approval of the repair quote before service can be completed.A final report is being submitted.If new information becomes available following completion of the device repair that changes the outcome of the investigation and associated medical device reporting, a follow-up or supplemental report will be completed.

• 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: 24894709
• Report Number: 2518422-2026-010928
• Device Sequence Number: 15957461
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown