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

Model Number	JP2100X16B
Medical Device Problem Codes	Computer Software Problem (1112); Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of the machine flow sensor drift above the specification 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.Dhr review was performed for the complaint device serial number, (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
The manufacturer received information alleging that a trilogy evo o2 japan device stopped operating with a ventilator inoperative alarm while in patient use.The sales representative powered on the device and verified that the device would not operate and that the screen displayed red.The device was replaced.The family reported that the alarm occurred when the device was powered off during an outing.There was no allegation of harm or injury reported.The ventilator was returned to the manufacturer for evaluation, and the reported issue was confirmed.Evaluation duplicated an error indicating that the amount of fluctuation in the flow sensor deviated from the standard.Restoration work was performed using dedicated software, which resolved the issue.Additionally, the device's flow sensor was replaced as a preventive action.Final testing, battery check, valve check, run-in testing, and cleaning were performed, and the device was confirmed to operate properly.The software version 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: 25325838
• Report Number: 2518422-2026-017344
• Device Sequence Number: 9676097
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 04/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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