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

Model Number	1054655
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the trilogy 100 device had shut down without any operation.The mechanical engineer (me) recognized that they device did not operate and started the power.The device operated without any problems, but they were requesting a replacement device.They alleged that the device had shut down without triggering an alarm.A sales representative went to the customer site for this issue.The sales representative stated, "there was history of the power being turned off observed in the alarm log." however, " the hospital nurse had not turned off and suspected that the cause was the device." the device was replaced with another one.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation.The manufacturer¿s service technician did not confirm the customer¿s issue and observed no "device inoperative" error codes in the device¿s event log.The manufacturer¿s service technician observed in the operation history that it was confirmed to turn off the power for this device.The manufacturer¿s service technician checked the operation of the device, but it was not duplicated.The manufacturer¿s service technician checked with a test device, but all test items was not duplicated.The manufacturer¿s service technician disassembled and visually inspected, and the device had no abnormalities found in it.The manufacturer¿s service technician alleged that "there were no abnormalities in the device and it was turned off due to a shutdown operation, rather that shutting down automatically." the manufacturer¿s service technician performed a repair test and run-in tests, along with battery and alarm checks.The manufacturer¿s service technician determined the device was operating properly, 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: 22639025
• Report Number: 2518422-2025-108320
• Device Sequence Number: 5194311
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: Other
• 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: 07/24/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2017
• 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