MAUDE Adverse Event Report: Respironics, Inc. Trilogy Evo, Korea; Ventilator, Continuous, Facility Use

Model Number	KR2110X15B
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned to the manufacture for periodic maintenance.There was no serious patient harm or injury that occurred or was reported.The trilogy evo was returned and evaluated by philips engineer.The device evaluation found that the power light on the equipment did not come on.The power supply was replaced to address the issue.During preventative maintenance, the air inlet foam filter and muffler assembly were also replaced.The device passed functional testing after repair and was returned to the customer.
Additional Manufacturer Narrative
The reported failure of 'the power light on the equipment did not come on' is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Dhr review was performed for the complaint device sn (b)(6).Review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: Trilogy Evo, Korea
• 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 ; +1(724)733-0200
• MDR Report Key: 50883133
• Report Number: 2518422-2026-046349
• Device Sequence Number: 16129439
• Product Code: CBK
• UDI-Device Identifier: 00606959055483
• UDI-Public: (01)00606959055483
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: KR2110X15B
• Device Catalogue Number: KR2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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