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

Model Number	EU2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); No Device Output (1435); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Following a software update, the trilogy evo is no longer responding, leading the user to be unable to access the menu.In addition, it is reported that the battery icon is empty even though it is fully charged.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient philips is currently investigating this complaint.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
The manufacturer previously reported: following a software update, the trilogy evo is no longer responding, leading the user to be unable to access the menu.In addition, it is reported that the battery icon is empty even though it is fully charged.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.This is non reportable due to the following: this notification has been reviewed for information received that after a repair/service software upgrade was attempted on a trilogy evo, the device became inoperative.The device was returned for evaluation, and it was confirmed that a ventilator inoperative condition occurred due to inconsistent software versions.The service center successfully upgraded the software upgrade without issue.The devices system board and display board were also replaced as a preventative action only.This information does not indicate a malfunction of the device, yet a result of the service being provided currently.It has been concluded that the trigger for this condition would not reoccur during use, which in turn could not have the possibility to cause harm injury to the user.Based on the available information, there is not enough evidence to indicate this issue is reportable to any regulatory agencies.No report will be filed with any regulatory agencies at this time.

• Brand Name: TRILOGY
• 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: 24674574
• Report Number: 2518422-2026-009934
• Device Sequence Number: 10144935
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2026

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 06/18/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/16/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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