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

Model Number FX2100X15B

Device Problems Communication or Transmission Problem (2896); Mechanical Jam (2983); Pressure Problem (3012)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

A trilogy evo ventilator was returned to the manufacturer for routine preventative maintenance.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, critical error code e-81, e-84 and e-150 was found in the ventilator's downloaded error log.The device's oxygen blending module board and filter was replaced to address the issue.The device was returned the customer.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18570752
• MDR Text Key: 333602986
• Report Number: 2518422-2024-04069
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959061019
• UDI-Public: 00606959061019
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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 Operator: Other
• Device Model Number: FX2100X15B
• Device Catalogue Number: FX2100X15B
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1