MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO O2 EASTERN EUROPE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	EE2100X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo o2, eastern europe ventilator was returned to a third-party service center for service due to an allegation that the "o2 too noisy, high o2 does not work properly".There was no harm or injury reported.The device was not reported to be in patient use.During the evaluation of the trilogy evo o2, eastern europe device at third-party service center, an evt_motor_shutdown error indicating a ventilator inoperative as a generic motor failure event code was discovered in the device's event log.This indicates that the device's blower is defective and will require replacement.Additionally, an evt_obm_valve_failure error indicating that the o2 proportional valve that controls the flow of o2 to the blower inlet is mechanically stuck closed or open was discovered in the device's event log.The device's oxygen blending module board needs to be replaced to address the issue.Furthermore, not related to the issue, the machine flow sensor has to be replaced due to an evt_drift_debug error indicating that the sensor offset during drift calculation is too high occurred after performing the pneumatic step.The air foam inlet filter, particulate filter will be replaced due to the 4-year preventive maintenance procedure.The blower bellow has to be replaced due to contamination.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.

• Brand Name: TRILOGY EVO O2 EASTERN EUROPE
• 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: 24160588
• Report Number: 2518422-2026-003130
• Device Sequence Number: 21081070
• Product Code: CBK
• UDI-Device Identifier: 00606959055698
• UDI-Public: (01)00606959055698
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: EE2100X15B
• Device Catalogue Number: EE2100X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2019
• 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