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

Model Number	EE2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received information alleging that after thirty minutes of testing a trilogy evo device, the device showed a ventilator service is required on it.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was returned to the manufacturer service center for evaluation, and the customer¿s complaint was not confirmed while using the gold detachable battery for testing of this device.During the evaluation it was noted that the service technician alleged that the detachable battery had caused the error code to have occur on the device.In conclusion, the device's detachable battery needs replaced to address the issue.Additionally, during the service of the device, the vanity cover and main housing needs replacing for physical damage unrelated to the reportable issue.The machine flow sensor, blower assembly, and one of the in-line proximal filter needs replacing for contamination unrelated to the reportable issue.The muffler assembly needs replacing for preventative maintenance unrelated to the reportable issue.The particulate filter and air inlet foam filter were replacing for preventative maintenance unrelated to the reportable issue.
Event or Problem Description
The manufacturer received information alleging that after thirty minutes of testing a trilogy evo device, the device showed a ventilator service is required on it.The device was not in use on a patient at the time of the occurrence.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.

• 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: 24472977
• Report Number: 2518422-2026-007068
• Device Sequence Number: 10308545
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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