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

Model Number	GB2110X15B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of evt_press_sensor_mismatch 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, h322784259b52 review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
A trilogy evo, great britain device was returned to a third-party service center for evaluation due to service required.There was no allegation of patient harm.During the evaluation, error evt_press_sensor_mismatch (error code 384) was found in the device error code log.The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve this error code.Additionally, error evt_presspair_err (error code 170) and error evt_drift_debug (error code 330) were found in the device error code log, and the printed circuit assembly needs to be replaced to address these error codes.Error evt_mach_flow_drift_log (error code 386) was also found in the device error code log, and the machine flow sensor needs to be replaced to address this error code.The service technician noted that all other errors were caused by contamination.The blower assy, tubing blower chassis and tubing fio2 were contaminated with dirt, and the air foam inlet filter, muffler, and particulate filter need replaced due to 4-year pm.After the evaluation and rework were complete, the device passed all testing.

• Brand Name: TRILOGY EVO
• 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: 25600171
• Report Number: 2518422-2026-025357
• Device Sequence Number: 9914322
• Product Code: CBK
• UDI-Device Identifier: 00606959054127
• UDI-Public: (01)00606959054127
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: GB2110X15B
• Device Catalogue Number: GB2110X15B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2021
• 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