MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; ABSORBENT, CARBON-DIOXIDE

Model Number DS2110X11B

Device Problems Contamination (1120); Failure to Recalibrate (1517)

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

Event Date 10/01/2022

Event Type  malfunction  

Event Description

A ventilator was returned to the manufacturer for `service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the device failed steps during testing.The device's blower assembly, machine flow sensor, system board, muffler assembly and internal tubing were replaced due to contamination.

• Brand Name: TRILOGY EVO
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• 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 15206
• MDR Report Key: 15690370
• MDR Text Key: 302579554
• Report Number: 2518422-2022-88072
• Device Sequence Number: 1
• Product Code: CBL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Date Manufacturer Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1