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

Model Number	AU2110X15B
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo ventilator was returned to the manufacturer for evaluation.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a failure of the device to power on was observed.The device's power supply/power cord was replaced to address the issue.In addition, the fio2 tubing was replaced.Contamination was observed therefore the tubing, housing, filter(s)/filter cap, filter cover were replaced.The following parts were broken therefore were replaced, filter(s)/filter cap.As a part of service, the particulate filter was replaced.The technician confirmed that there was no problem found and replaced other there is no other information provided at this time.A request for additional information has been made to determine the actual failure or reason why other parts were repaired/replaced.A supplemental report will be filed if additional information becomes available at a later time.
Additional Manufacturer Narrative
Previously reported by the manufacturer: a trilogy evo ventilator was returned to the manufacturer for evaluation.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a failure of the device to power on was observed.The device's power supply/power cord was replaced to address the issue.In addition, the fio2 tubing was replaced.Contamination was observed therefore the tubing, housing, filter(s)/filter cap, filter cover were replaced.The following parts were broken therefore were replaced, filter(s)/filter cap.As a part of service, the particulate filter was replaced.The technician confirmed that there was no problem found and replaced other.There is no other information provided at this time.A request for additional information has been made to determine the actual failure or reason why other parts were repaired/replaced.A supplemental report will be filed if additional information becomes available at a later time.New/ additional eval information: a request was made to gather additional information regarding the actual failure/repairs.A trilogy evo ventilator was returned to the manufacturer for evaluation.There was no harm or injury reported.During the evaluation of the trilogy evo at the manufacturer's service center, a failure of the device to power on (not charging while connected to the main power) was observed.The technician confirmed the system board power supply was faulty therefore, the device's power supply/power cord was replaced to address the issue.In addition, the fio2 tubing was replaced.Contamination (dust) was observed therefore the tubing, housing, filter(s)/filter cap, filter cover were replaced.The filter(s)/filter cap/cover was found to have deep scratches therefore was replaced.As a part of service, the particulate filter and inlet filter were replaced.H05 power cord was replaced to validate longevity between services.The technician confirmed that there were no actionable errors in error log.It was confirmed that the device ran overnight.No further faults/ errors were found.The unit was calibrated, confirmed to be working correctly and passed all test.The unit was decontaminated before leaving hrf repair bench for dispatch and was dispatched on default settings.Box h coding remains the same.

• Brand Name: TRILOGY EVO
• 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: 22413795
• Report Number: 2518422-2025-107129
• Device Sequence Number: 21248797
• Product Code: CBK
• UDI-Device Identifier: 00606959051980
• UDI-Public: (01)00606959051980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: AU2110X15B
• Device Catalogue Number: AU2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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