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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy evo iberia ventilator was returned to a third-party service center for four-year preventative maintenance.There was no allegation of device malfunction.There was no allegation of harm or injury reported.The device was not reported to be in patient use.During the "in process" evaluation of the trilogy evo iberia device at third-party service center, an evt_battery_not_charging_fault error code was discovered in the device's event log.The root cause is a defective battery and the device's internal battery needs to be replaced to address the issue.Additionally, not related the device's system board tubing is contaminated; and it needs to be replaced.Per the requirement of the four-year preventative maintenance the device's air foam inlet filter, particulate filter and muffler will be replaced.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.The incorrect event date was entered in box b: adverse event or product problem.This report serves as a correction, and the event date has been updated to reflect the accurate information.
Event or Problem Description
A trilogy evo iberia ventilator was returned to a third-party service center for four-year preventative maintenance.There was no allegation of device malfunction.There was no allegation of harm or injury reported.The device was not reported to be in patient use.During the "in process" evaluation of the trilogy evo iberia device at third-party service center, an evt_battery_not_charging_fault error code was discovered in the device's event log.The root cause is a defective battery and the device's internal battery needs to be replaced to address the issue.Additionally, not related the device's system board tubing is contaminated; and it needs to be replaced.Per the requirement of the four-year preventative maintenance the device's air foam inlet filter, particulate filter and muffler will be replaced.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/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: 24626168
• Report Number: 2518422-2026-009709
• Device Sequence Number: 9173811
• 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,Followup
• Report Date (Section B): 03/18/2026

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: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown