MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR, JAPAN-RENTAL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	R1054655
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer¿s service center, an error code related to the temperature of the internal battery was observed.There was no reported patient involvement.The manufacturer¿s service technician observed error code e-246 (internal battery) in the device¿s event log.The service technician replaced the device¿s power management printed circuit assembly board to address e-246.Additional findings not related to the malfunction/issue was the following parts were proactively replaced on the device: pollen filter, exhaust fan assembly, and 43-micron filter.After the parts were replaced on the device, the manufacturer¿s service technician performed the repair and run-in tests, along with the battery and valve checks.The manufacturer¿s service technician determined the device was operational, and it was cleaned.

• Brand Name: TRILOGY100 VENTILATOR, JAPAN-RENTAL
• 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: 21953627
• Report Number: 2518422-2025-105128
• Device Sequence Number: 8548146
• Product Code: CBK
• UDI-Device Identifier: 00606959033894
• UDI-Public: (01)00606959033894
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: R1054655
• Device Catalogue Number: R1054655
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/02/2025
• 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