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

Model Number DS2110X11B

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

A ventilator was returned to a third-party service center for service of screen not working.During the evaluation of the device at the factory authorized service center, the complaint was confirmed.The device's display screen was replaced to address the issue.Additional findings not related to the issue; the muffler and filter was dirty, and the muffler and trilogy evo air inlet foam filter was replaced to address the issue.

Manufacturer Narrative

H3 other text : device was evaluated by third-party service center.

• Brand Name: TRILOGY EVO
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE.
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19165483
• MDR Text Key: 340965483
• Report Number: 2518422-2024-21716
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959051942
• UDI-Public: 00606959051942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1