MAUDE Adverse Event Report: Respironics, Inc. TRILOGY EVO, JAPAN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	RJP2110X16B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported by the (b)(6) that the patient died on (b)(6) 2026 after a trilogy evo device had been on standby for about an hour.The patient had reportedly been using the mask for 24 hours, and it was reported that the patient became unresponsive at around 16:55.The patient was already unresponsive when the ambulance crew arrived.It was reportedly determined that transportation was not necessary, and the patient was pronounced deceased at the scene.As the death was confirmed by emergency medical personnel, the cause of death and the estimated time of death were still under investigation.Upon review of the trend data from the police, the waveform was interrupted approximately from 15:50 to 16:45.Since there was a period in which no waveform was recorded in the trend data, it is presumed that the patient may not have received ventilation for approximately one hour, which may have contributed to the death.Regarding the device, it was reported that the case was being handled as a police matter and that the device would also be examined at the police station.Therefore, it was unclear when the device could be returned to philips.According to the detective's impression, the device itself did not appear to have a problem, and it seemed more likely that the device had been placed in standby mode by someone.As for the cause of death and other related details, the investigation by the police is reportedly still ongoing.Should new device evaluation information be received, a follow-up report will be filed.

• Brand Name: TRILOGY EVO, 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: 50143901
• Report Number: 2518422-2026-041029
• Device Sequence Number: 13426097
• Product Code: CBK
• UDI-Device Identifier: 00606959051973
• UDI-Public: (01)00606959051973
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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
• Device Model Number: RJP2110X16B
• Device Catalogue Number: RJP2110X16B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female