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

Model Number	DS2110X11B
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo device was returned to a third-party service center for preventative maintenance.There is no allegation of serious or permanent harm or injury.The device was not in patient use.The evaluation is still in process but discovered that the device had black smoke on the main housing, outlet side panel, and rear cover.Additionally, the device had dirt contamination in the blower assembly, blower bellow seal, blower mount, blower cap, blower chassis, cooling fan assembly, and fan retainer.The other components had unspecified contamination, machine flow sensor, pca tubing, blower chassis, fio2 tubing, and low flow o2 tubing.In addition, the muffler assembly, air inlet foam filter, 3 way solenoid valve, and proportional valves need to be replaced as part of preventive maintenance.The manufacturer's investigation is ongoing.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the previous report and to update the coding.It was previously reported that "a trilogy evo device was returned to a third-party service center for preventative maintenance.There is no allegation of serious or permanent harm or injury.The device was not in patient use.The evaluation is still in process but discovered that the device had black smoke on the main housing, outlet side panel, and rear cover.Additionally, the device had dirt contamination in the blower assembly, blower bellow seal, blower mount, blower cap, blower chassis, cooling fan assembly, and fan retainer.The other components had unspecified contamination, machine flow sensor, pca tubing, blower chassis, fio2 tubing, and low flow o2 tubing.In addition, the muffler assembly, air inlet foam filter, 3 way solenoid valve, and proportional valves need to be replaced as part of preventive maintenance." upon further review, the findings regarding the reported black smoke showed no evidence of a thermal event.There were no reports of death, serious harm, or injury associated with this incident.Analysis of previous events indicates that an adverse event has not occurred due to this allegation, nor is it likely to recur if the allegation were to happen again.Additionally, a review of the risk file suggests that the potential for a serious adverse event resulting from this incident is unlikely.Therefore, this event is not reportable under fda 21 cfr part 803, as it does not meet the criteria for death, serious injury, or reportable product malfunction.

• 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: 25633656
• Report Number: 2518422-2026-026016
• Device Sequence Number: 9379349
• Product Code: CBK
• UDI-Device Identifier: 00606959051942
• UDI-Public: (01)00606959051942
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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
• Operator of Device: Other
• Device Model Number: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown