MAUDE Adverse Event Report: Respironics, Inc. Trilogy Evo, O2, Japan; Ventilator, Continuous, Facility Use

Model Number	JP2100X16B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2026
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient passed away on (b)(6) 2026.A clinical assessment was performed.On (b)(6) 2026, the patient was found deceased in the morning.Philips was contacted because there was concern that the device may have become disconnected during this period, and a request was made for detailed device logs, including power on/off times, alarm history, setting changes, and other operation records.Reported alarms during the event included low tidal volume, low minute ventilation, and circuit disconnect.A nurse noted that the ventilator was found disconnected at some point.It was reported that the cause was determined to be human error rather than a device-related issue.Based on the information currently provided and available, device cause and/or contribution to the reported event cannot currently be confirmed, nor refuted, based on the evidence present.The device evaluation has not yet begun.At this time, we are unable to confirm the alleged malfunction.If any additional information is received once the investigation is complete, a follow-up report will be filed.

• Brand Name: Trilogy Evo, O2, 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 ; +1(724)733-0200
• MDR Report Key: 50239300
• Report Number: 2518422-2026-043142
• Device Sequence Number: 10296890
• Product Code: CBK
• UDI-Device Identifier: 00606959055582
• UDI-Public: (01)00606959055582
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: JP2100X16B
• Device Catalogue Number: JP2100X16B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown