MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY O2 VENTILATOR, JAPAN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	R1040004TP
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from the hospital alleging the power source suddenly switched to the detachable battery while the trilogy o2 device was on ac power.The customer alleged that an ac power disconnect alarm had occurred at the time of this issue.The device was replaced with another device.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The trilogy o2 device was returned to the manufacturer service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the power supply printed circuit assembly (pca) had caused the issue to occur on the device.In conclusion, the device's power supply pca was replaced to address the issue.The root cause is confirmed at this time.

• Brand Name: TRILOGY O2 VENTILATOR, JAPAN
• 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: 24560482
• Report Number: 2518422-2026-008904
• Device Sequence Number: 8932838
• Product Code: CBK
• UDI-Device Identifier: 00606959025394
• UDI-Public: (01)00606959025394
• 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
• Report Date (Section B): 03/10/2026

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: R1040004TP
• Device Catalogue Number: R1040004TP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2018
• 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