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

Model Number DS2110X11B

Device Problems Electrical /Electronic Property Problem (1198); Decrease in Pressure (1490); Device Contamination with Chemical or Other Material (2944); Gas/Air Leak (2946); Erratic Results (4059)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging a red service alarm condition occurred.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported: the manufacturer received information alleging a red service alarm condition occurred.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.It was later reported by a clinical director that the evo is not sending data or data incomplete.Around 2 hours per day its reporting: patient deemed non-compliant, but on further review patient has been using.When card is downloaded it reports a much higher usage/compliance.Evaluation: the trilogy evo was sent to a third-party service center for evaluation.During the evaluation of the device at the third-party service center, it was confirmed that the device failed the system leak verification.The pressure dropped over 10s.The blower, hoses and machine flow were contaminated with saline solution.The following parts were replaced to address the issue: blower assembly, blower bellow seal, blower mounts, machine flow sensor, muffler assembly, tubing system pca, tubing blower chassis, tubing fio2, tubing -low flow o2.The air inlet foam filter was replaced per remediation.

• 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: 18411347
• MDR Text Key: 331532021
• Report Number: 2518422-2023-38349
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DS2110X11B
• Device Catalogue Number: DS2110X11B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1