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

Model Number	JP2100X16B
Medical Device Problem Codes	Circuit Failure (1089); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Dhr review was performed for the complaint device serial number, h356009641074 review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
The manufacturer received information from a nurse alleging that the screen suddenly went dark while touching the screen to check settings on a trilogy evo device.The nurse stated that the screen switched to an hourglass with a blue background after that, and the screen repeatedly became completely dark.The airflow kept being delivered at this time.The airflow also stopped while attempting to turn off the power using various operations, such as holding the button.The nurse informed the sales representative that initially there was a yellow alarm that sounded consistently, and a red alarm occurred when the power cord was unplugged for the device replacement.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 evo was returned to the manufacturer service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the devices display printed circuit assembly (pca) had caused the screen to go dark on the device.In conclusion, the device's display pca was replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the system pca was replaced for an error code, start stop latch set stuck, that was observed on the device's error log.This was unrelated to the reportable issue.The blower assembly was replaced for a noise that was occurring on it.This was unrelated to the reportable issue.The air inlet foam filter and particle filter were replaced for preventative maintenance unrelated to the reportable issue.The software was upgraded from 1.06.10.00 to 1.06.15.00.

• 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 ; 7247330200
• MDR Report Key: 25337394
• Report Number: 2518422-2026-017631
• Device Sequence Number: 10002868
• Product Code: CBK
• UDI-Device Identifier: 00606959055582
• UDI-Public: (01)00606959055582
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: Other
• Device Model Number: JP2100X16B
• Device Catalogue Number: JP2100X16B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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