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

Model Number	CA1040000
Medical Device Problem Codes	No Display/Image (1183); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator is returning to the manufacturer for preventive maintenance.There was no harm or injury reported.The customer indicated the device's display was blank, the blower hours were high, and there was liquid ingress in the interface board.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy device was returned for preventive maintenance due to an allegation the device's display was blank, the blower hours were high, and there was liquid ingress in the interface board.The device was evaluated by the manufacturer's field service technician and the customer's complaint was confirmed.The device's system board was replaced to address the blank display.The blower motor was replaced due to the increased hours of use, and the interface board was replaced due to the liquid ingress.There was no allegation of malfunction for the blower motor and interface board.The device was tested and passed all final testing.
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy device was returned for preventive maintenance due to an allegation the device's display was blank, the blower hours were high, and there was liquid ingress in the interface board.The device's system board was replaced to address the blank display.The blower motor was replaced due to the increased hours of use, and the interface board was replaced due to the liquid ingress.There was no allegation of malfunction for the blower motor and interface board.The device was tested and passed all final testing.The evaluation results code was not previously reported.The code was 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: 21517799
• Report Number: 2518422-2025-102604
• Device Sequence Number: 12875531
• Product Code: CBK
• UDI-Device Identifier: 00606959022799
• UDI-Public: (01)00606959022799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093905
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: CA1040000
• Device Catalogue Number: CA1040000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/15/2025; Not provided
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 08/14/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2020
• 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