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

Model Number	GB2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report that a trilogy evo ventilator was returned for service.No patient harm or injury was reported.The device was evaluated at a third-party service center.During the evaluation of the device, the device log files were successfully downloaded and reviewed in full.A ¿ventilator service required¿ alarm was identified due to failure of the internal battery system.Specifically, this condition may have resulted from the battery not being detected, failure of the system printed circuit assembly (pca) as indicated by terminal voltage, wake voltage, or smbus communication errors, or an internal battery failure.The internal battery was replaced to correct the issue.In addition, a ¿vent inoperative¿ error was identified, attributed to the therapy cpu remaining in boot monitor software.The system printed circuit assembly (pca) was replaced to correct the issue.Additionally, unrelated to the reported malfunction, an error was observed related to the detachable li-ion battery, including a permanent failure indication and a condition in which the battery was connected with v_wake_det < 10.000v, potentially associated with detachable battery failure, v_wake_det or check_wake_det circuit failure, or an adc fault.The detachable battery was replaced to address this finding.An internal and external inspection of the device was performed, and no cosmetic damage was observed.No alarms were noted during bench run in testing.As part of preventive maintenance, the particulate filter, air inlet foam filter, and muffler assembly were replaced.The machine flow sensor was replaced as per the field safety notice.Following service and testing, the device passed all functional testing.
Additional Manufacturer Narrative
The reported failure of vent inoperative error attributed to the therapy cpu remaining in boot monitor software 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.The reported failure of ventilator service required alarm due to failure of the internal battery system 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 h32267606967c, review confirms that the device met the final acceptance criteria and was released for final distribution.

• 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: 25230666
• Report Number: 2518422-2026-015070
• Device Sequence Number: 5238919
• Product Code: CBK
• UDI-Device Identifier: 00606959054127
• UDI-Public: (01)00606959054127
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: GB2110X15B
• Device Catalogue Number: GB2110X15B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• 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