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

Model Number	EE2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator was returned to the third-party service center for evaluation of the allegation of a malfunction of the device.There was no patient involvement, and no harm or injury reported.On device evaluation, a ventilator inoperative error code was noted in the device error log that indicates data in the electronically erasable programable read-only memory (eeprom) is corrupt on system/central processing unit (cpu).The device is pending completed evaluation and repair.If additional information is received, a follow-up report will be submitted.

• 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: 25391474
• Report Number: 2518422-2026-019026
• Device Sequence Number: 12063433
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: EE2110X15B
• Device Catalogue Number: EE2110X15B
• 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: 06/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown