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

Model Number	IT2110X21B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a "ventilator not operative" alarm occurred on a trilogy evo ventilator.The device was not in use on a patient at the time of the occurrence.The trilogy evo ventilator has not yet been received at the third-party service center for evaluation.At this time, we are unable to confirm the alleged "ventilator not operative" alarm.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The trilogy evo ventilator was returned to the third-party service center for the report of a ventilator inoperative condition.There was no patient involvement, and no harm or injury reported.On device evaluation, error code e-47 had occurred indicating the internal lithium-ion battery had a permanent failure and required replacement of the internal lithium-ion battery.Error codes e-194 and e-195 had occurred indicating the power software version string does not match the overall system version string, and the user interface (ui) software version string does not match the overall system version string, respectively.Reinstallation of the application software is advised; however, in this case, evaluation reported the system printed circuit board assembly needed replaced to address this issue.Additional findings not related to the malfunction/issue: error code e-52 had occurred indicating the detachable li-ion battery is reporting a permanent failure.This is not the final source of power to the device.Error code e-290 indicating a start/stop latch failure was noted as well as error code e-144 which indicates the motor controller has proceeded to the shutdown state due to an error with the motor.The printed circuit board assembly needed replaced for both e-290 and e-144.The internal battery door was damaged, the blower and machine low sensors are contaminated, and the sn/mn label was damaged.As part of preventative maintenance, the muffler assembly, particulate filter and air inlet foam filter needed replaced, maintenance label will be added.

• 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: 22840057
• Report Number: 2518422-2025-109221
• Device Sequence Number: 21152152
• Product Code: CBK
• UDI-Device Identifier: 00606959055421
• UDI-Public: (01)00606959055421
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: IT2110X21B
• Device Catalogue Number: IT2110X21B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown