MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; 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	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a malfunction of a trilogy 100 ventilator's touchscreen.It was reported that the screen saver would not cancel, even after pressing the switch.There was no harm or injury reported.The trilogy 100 was returned to the manufacturer for evaluation and the customer's complaint was confirmed.Although there was airflow being delivered, the whole screen remained completely black, and the display was not viewable.The technician recommended replacing the device's lcd display to address the issue.The root cause has been determined to be a failure in the lcd.The lcd display was returned to the manufacturer's product investigation laboratory for further review.The product investigation laboratory could not duplicate the failure of the lcd display when installed into the trilogy test bed.The lcd display functioned as designed.The display was scrapped.Additionally, not related to the malfunction, the left down button is overly sensitive as if pressed twice when only pressing one time.The front panel board was replaced to address the issue.The technician performed repair tests, alarm check, battery check, run-in tests, and cleaning then confirmed that the unit operated properly.The software was confirmed as 14.1.03.The product investigation laboratory installed the front panel board into a trilogy test bed and pressed all the key buttons numerous times without failure.The product investigation laboratory tested all the buttons, leds and speakers and determined that the front panel board operates as designed and could not duplicate the allegations.

• Brand Name: TRILOGY 100
• 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: 22968702
• Report Number: 2518422-2025-109621
• Device Sequence Number: 9062142
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2017
• 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