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

Model Number	DS2200X11B
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The reported failure of the trilogy evo system 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 the trilogy ev300 ventilator failed to have a software update successfully installed during service.There was no patient involvement, and no harm or injury reported.On device evaluation, ventilator inoperative error code e-156 was noted in the error log indicating the therapy central processing unit (cpu) was still running in boot monitor software.The system printed circuit board assembly required replacement to address this issue.Additional findings not related to the malfunction/issue: information received that after a repair/service software upgrade was attempted on a trilogy evo the device became inoperative.This information does not indicate a malfunction of the device, yet a result of the service being provided.It has been concluded that the trigger for this condition would not occur during normal operation and use on a patient; therefore, posing no additional safety risk for a patient.Based on the available information, there is not enough evidence to suggest if this reported issue were to recur that it would be likely to cause or contribute to death or serious injury.On physical inspection, the internal battery was missing and required replacement.Parts of the enclosure were damaged or missing and required replacement.

• 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: 25546713
• Report Number: 2518422-2026-023573
• Device Sequence Number: 10731841
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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