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

Model Number	1054655
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the screen had blacked out.The patient informed the sales representative that there was no problem with the operation of the device.The sale representative observed the screen being blacked out and replaced the device with another one.There was no harm or injury reported.The device has not been returned to the manufacturer.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 received information alleging the screen had blacked out.The patient informed the sales representative that there was no problem with the operation of the device.The sale representative observed the screen being blacked out and replaced the device with another one.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed during a device check.The manufacturer's service technician stated that since the device was operating without any changes even after the screen turned black, "it is assumed that a failure occurred in the liquid crystal display (lcd) backlight.The manufacturer's service technician replaced the device's lcd to prevent recurrence of this issue.Additional findings not related to the malfunction/issue was the following parts were proactively replaced by the manufacturer's service technician for this device: pollen filter, exhaust fan assembly, and forty-three micron filter.After the manufacturer's service technician had replaced all of the parts on the device, the manufacturer's service technician performed the final and run-in tests, along with the battery and valve checks.The manufacturer's service technician found the device operational, and it was cleaned.

• Brand Name: TRILOGY
• 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: 22047456
• Report Number: 2518422-2025-105858
• Device Sequence Number: 12986535
• Product Code: CBK
• UDI-Device Identifier: 00606959025387
• UDI-Public: (01)00606959025387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2018
• 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