MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EV300, USA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	DS2200X11B
Medical Device Problem Codes	Circuit Failure (1089); Gas Output Problem (1266); Mechanical Problem (1384); Failure to Calibrate (2440); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of a pneumatic and active exhalation setpoint test 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: review of the dhr for this device, serial number (b)(6) did not find any non-conformances or abnormalities related to the reportable malfunction/ allegation identified in this complaint record during testing of the device prior to distribution.
Event or Problem Description
The manufacturer received information alleging a trilogy evo failed to deliver accurate fio2 percentages.At 21% the device shows 26% and at 100% the device shows 80%.There was no harm or injury reported.There was no evidence the device was in patient use.The device was returned to the manufacturer for bench repair.During the evaluation the device failed a pneumatic setpoint 80 test step and an active exhalation pilot difference test step and failed fio2 calibration.The device's machine flow sensor, three-way solenoid valve and fio2 sensor need to be replaced to address the issues.Additionally, service required alarm conditions indicating the proportional valve is stuck open/closed and an o2 regulation alarm indicating the o2 concentration was not within the fio2 setpoint were observed.The device's oxygen blending module and system board need to be replaced to address the issues.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: TRILOGY EV300, USA
• 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: 25612446
• Report Number: 2518422-2026-025832
• Device Sequence Number: 20217200
• Product Code: CBK
• UDI-Device Identifier: 00606959052017
• UDI-Public: (01)00606959052017
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: DS2200X11B
• Device Catalogue Number: DS2200X11B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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