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

Model Number	EE2110X15B
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo ventilator was returned to a third-party service center for service.There was no harm or injury reported.A ventilator service required alarm was found in the device error log indicating the internal or detachable li-ion battery was not charging due to a hardware fault for greater than, or equal to 1 minute.The unit was tested with a gold detachable battery because the unit came without one.The device was left running for 4 hours and no alarm appeared.It is possible that the detachable battery used by the customer is faulty and needs to be replaced.This issue is reportable because the system cannot charge the internal battery under this condition.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements as defined in the contractual agreement with the third-party servicer.The device history record has been reviewed and approved by the third-party servicer's quality assurance.

• 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: 22579178
• Report Number: 2518422-2025-108164
• Device Sequence Number: 18450940
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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