MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EV300; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	FX2200X15B
Medical Device Problem Codes	Circuit Failure (1089); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.The ventilator was due a service, but when it was in clinical use the end users were getting alarms.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log.The device's 3-way solenoid valve & system board, and fio2 sensor were replaced to resolve test failure.The device passed performance verification.
Additional Manufacturer Narrative
Previously, a ventilator was returned to the manufacturer for service.The ventilator was due a service, but when it was in clinical use the end users were getting alarms.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log.The device's 3-way solenoid valve & system board, and fio2 sensor were replaced to resolve test failure.The device passed performance verification.The device was returned to the manufacturer's product investigation laboratory (pil).Pil was unable to confirm the failure of the system pca, solenoid, and fio2 cable.Pil installed the system pca, solenoid valve and fio2 cable on the trilogy evo stb and ran therapy for approximately 1 hour.Pil concluded that the system pca , solenoid valve and fio2 operate without an issue.Pil retrieved and reviewed the event log and found nothing of note.Pil concluded that the system pca, solenoid valve and fio2 operate as designed.The trilogy evo cable, system pca to fio2 sensor has been scrapped.

• Brand Name: TRILOGY EV300
• Common Device Name: 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: 17907241
• Report Number: 2518422-2023-26173
• Device Sequence Number: 7543441
• Product Code: CBK
• UDI-Device Identifier: 00606959061033
• UDI-Public: 00606959061033
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Model Number: FX2200X15B
• Device Catalogue Number: FX2200X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown