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

Model Number	JP2110X16B
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) dhr review was performed for the complaint device serial number, review confirms that the device met the final acceptance criteria and was released for final distribution.The reported failure of the printed circuit board assembly is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary 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.
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator was returned to the manufacturer's service center for evaluation for the allegation that the turned red and the device was inoperative.There was no patient involvement, and no harm or injury reported.One evaluation, immediately after powering on the unit, the reported ¿ventilator inoperative¿ alarm was duplicated.Review of the error log confirmed the occurrence of ventilator inoperative error code e-262, which is recorded when the electronically erasable programable read-only memory (eeprom) data on the system printed circuit board assembly (pca) becomes corrupted.Therefore, the system pca containing the eeprom was replaced.Additional findings not related to the malfunction/issue: the following parts were replaced to prevent failure: air inlet foam filter, particulate filter, muffler assembly.Software version was upgraded from 1.06.10.00 to 1.06.15.00.The device passed final testing and was confirmed to operate properly.

• 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 ; 7247330200
• MDR Report Key: 25654132
• Report Number: 2518422-2026-027485
• Device Sequence Number: 5902968
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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
• Device Model Number: JP2110X16B
• Device Catalogue Number: JP2110X16B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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
• Patient Sex: Unknown