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

Model Number	EU2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator had critical error codes occur.There was no patient involvement, and no harm or injury reported.Information received with details for this device trilogy evo sn h32070825d37f there was error code e0047 indicating the internal battery failed and error code e0156, which represents a ventilator inoperative condition of the therapy central processing unit (cpu) still running in boot monitor software.Philips is currently investigating this complaint; however, the device examination has not yet begun because the device has not yet been returned to the manufacturer for evaluation.At this time, the manufacturer is unable to confirm the alleged malfunction.If additional information is received, a follow-up report will be filed.

• 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: 25304460
• Report Number: 2518422-2026-016803
• Device Sequence Number: 9368530
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2021
• 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