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

Model Number	FX2100X15B
Medical Device Problem Code	No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator's device settings were unable to be changed due to the touchscreen not responding.There was no harm or injury reported.The device was not in patient use.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator's device settings were unable to be changed due to the touchscreen not responding.There was no harm or injury reported.The device was not in patient use.The device was returned to a third-party service center for evaluation.The customer's complaint was unable to be duplicated.No malfunction of the device was noted.Preventive maintenance did not reveal any issues.The device software was updated.No repairs were needed at this time.

• Brand Name: TRILOGY EVO
• 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: 22382918
• Report Number: 2518422-2025-107014
• Device Sequence Number: 7054027
• Product Code: CBK
• UDI-Device Identifier: 00606959061019
• UDI-Public: (01)00606959061019
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: FX2100X15B
• Device Catalogue Number: FX2100X15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2020
• 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