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

Model Number	EE2110X15B
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a red display, non-functioning ventilator occurred on a trilogy evo.The device was not reported to be in patient use at the time of the allegation.The device has been received by the third-party service center and is currently awaiting evaluation.A supplemental report will be submitted as due.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a red display, non-functioning ventilator occurred on a trilogy evo.The device was not reported to be in patient use at the time of the allegation.The device has been received by the third-party service center and is currently awaiting evaluation.A supplemental report will be submitted as due.New information/evaluation: the trilogy evo ventilator was returned to the third-party service center for evaluation.The device was not in use on a patient at the time of the occurrence.During the evaluation the customer complaint was confirmed.An error code in relation to mcl_foc_shutdown was recorded in the device event log.The blower was replaced to address the issue.Additionally, during the service of the device, it was noted that the unit was heavily contaminated with dust.The machine flow sensor and 2 in-line filter prox.Are contaminated.Due to the 4-year preventive maintenance, the muffler assembly, particulate filter and air inlet foam filter were replaced, and the maintenance label was added.The vanity cover was missing the silver button ornaments; and therefore, was replaced.Based on the available information, there is not enough evidence to indicate this issue is reportable to any regulatory agencies.There is no patient harm associated with this notification, and no risk of harm if the event should recur and does not meet the definition of a reportable complaint per the fda regulations (21 cfr 803).

• 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: 23383416
• Report Number: 2518422-2025-111321
• Device Sequence Number: 8644665
• Product Code: CBK
• UDI-Device Identifier: 00606959055544
• UDI-Public: (01)00606959055544
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Operator of Device: Other
• Device Model Number: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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