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

Model Number	JP2100X16B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of the oxygen blending module 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, h2966564269df review confirms that the device met the final acceptance criteria and was released for final distribution.
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 the oxygen regulation alarm did not sound when the hose was detached after oxygen was delivered during a periodical device check.There was no patient involvement, and no harm or injury reported.On device evaluation, the reported issue was not reproduced.Review of the device's event log confirmed record of the alleged device issue.The device had verification testing completed and passed the testing.As a preventative measure, the oxygen blending module subassembly was replaced.Functional testing with adding oxygen was performed after the replacement and confirmed there were no abnormal noises.Additionally, it was confirmed that the reported issue did not occur after component replacement.The device passed final testing.

• 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: 25350278
• Report Number: 2518422-2026-017940
• Device Sequence Number: 10668856
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: JP2100X16B
• Device Catalogue Number: JP2100X16B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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
• Patient Sex: Unknown