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

Model Number FR2110X14B

Device Problems Electrical /Electronic Property Problem (1198); Increase in Pressure (1491); Gas/Air Leak (2946)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a trilogy evo ventilator was missing a pre alert.There was no harm or injury reported.The device was sent to a third-party service center for evaluation.During the evaluation of the device at the third-party service center, error code e-132 (active exhalation valve leak) and e-155 (ventilator inoperative) code was found in the ventilator's downloaded error log.The device was repaired and returned to the customer.The faulty component will be sent to the phillips investigation lab (pil) for further investigation.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 18992482
• MDR Text Key: 338943459
• Report Number: 2518422-2024-15780
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: 00606959055506
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1