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

Model Number	1032804
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator's lcd screen was not displaying.The call stated that the airflow was still being delivered.The sales representative arrived at the patient's home and confirmed that the issue had been resolved and the screen was displaying.The sales representative checked the alarm log and event log but was unable to find any such errors.The patient's family stated that even when they intentionally generated an alarm, only the sound silence button lighted in red, and the screen remained dark.The sales representative replaced the device to an alternative one.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the complaint was unable to be confirmed by operational checking.It was confirmed that no error indicating a device failure had been recorded in the error log.It was determined that the issue was caused by a failure to the lcd screen.The repair was cancelled, and the unit will be scrapped due to the lease being up.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a ventilator's lcd screen was not displaying.The call stated that the airflow was still being delivered.The sales representative arrived at the patient's home and confirmed that the issue had been resolved and the screen was displaying.The sales representative checked the alarm log and event log but was unable to find any such errors.The patient's family stated that even when they intentionally generated an alarm, only the sound silence button lighted in red, and the screen remained dark.The sales representative replaced the device to an alternative one.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the complaint was unable to be confirmed by operational checking.It was confirmed that no error indicating a device failure had been recorded in the error log.It was determined that the issue was caused by a failure to the lcd screen.The repair was cancelled, and the unit will be scrapped due to the lease being up.The original lcd display was sent to the philips investigation lab (pil) for further evaluation.Pil was not able to duplicate the failure of the lcd display.They confirmed that the lcd display functioned as designed.The display was scrapped.The evaluation results and conclusion code grids have been updated to reflect this new information.

• 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: 20354515
• Report Number: 2518422-2024-101411
• Device Sequence Number: 3579195
• Product Code: CBK
• UDI-Device Identifier: 00606959025370
• UDI-Public: (01)00606959025370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 1032804
• Device Catalogue Number: 1032804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2017
• 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