MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO O2 INT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number FX2100X15B

Device Problem Device Sensing Problem (2917)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

A ventilator was returned to the manufacturer.There was no harm or injury reported.During the evaluation of the device at the manufacturer service center, the device was found to have a defective external flow sensor and fio2 sensor.The fio2 sensor was replaced to address the issue.

• Brand Name: TRILOGY EVO O2 INT
• 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: 18778933
• MDR Text Key: 336330141
• Report Number: 2518422-2024-09711
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1