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

Model Number	FX2200X15B
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator failed an active exhalation verification test step failure during testing.There was no harm or injury reported.The device was not in patient use.The manufacturer's field service engineer evaluated the device onsite and states the device's three-way solenoid valve and proportional valve need to be replaced to address the issue.The device is to return for bench repair.The manufacturer's investigation is ongoing.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator failed an active exhalation verification test step failure during testing.There was no harm or injury reported.The device was not in patient use.The manufacturer's field service engineer evaluated the device onsite and states the device's three-way solenoid valve and proportional valve need to be replaced to address the issue.The device is to return for bench repair.The device evaluation has been completed, and the device's solenoid valve only was replaced to address the test failure.No actionable errors were noted in the device's downloaded event log.No other components required replacement.The device was tested and passed all final testing.

• Brand Name: TRILOGY EV300
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24019021
• Report Number: 2518422-2026-001315
• Device Sequence Number: 18789348
• Product Code: CBK
• UDI-Device Identifier: 00606959061033
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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
• Device Model Number: FX2200X15B
• Device Catalogue Number: FX2200X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/21/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown