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

Model Number	FR2110X14B
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	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer previously reported information received alleging "preventive maintenance to be carried out" for a trilogy evo, france device.There was no allegation of patient harm.During evaluation of the trilogy evo, france device at a third-party service center, an error evt_internal_batt_failed was discovered in the event log.The technician recommended replacing the device's internal battery to address the issue.No repair was performed; the unit was not serviced due to customer's request.Additionally, the detachable battery needs to be replaced to address an evt_detach_batt_failed error.The system board needs to be replaced to address evt_hard_power_fail and evt_start_stop_latch_reset_stuck codes found in the event log.Upon further review, it was discovered that the information was received by the manufacturer on 08/23/2024.The become aware date has been updated in this report to reflect this information.
Event or Problem Description
The manufacturer received information alleging "preventive maintenance to be carried out" for a trilogy evo, france device.There was no allegation of patient harm.During evaluation of the trilogy evo, france device at a third-party service center, an error evt_internal_batt_failed was discovered in the event log.The technician recommended replacing the device's internal battery to address the issue.No repair was performed; the unit was not serviced due to customer's request.Additionally, the detachable battery needs to be replaced to address an evt_detach_batt_failed error.The system board needs to be replaced to address evt_hard_power_fail and evt_start_stop_latch_reset_stuck codes found in the event log.

• Brand Name: TRILOGY EVO, FRANCE
• 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: 23416128
• Report Number: 2518422-2025-111429
• Device Sequence Number: 10300068
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: (01)00606959055506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: FR2110X14B
• Device Catalogue Number: FR2110X14B
• 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: 08/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown