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

Model Number	FR2110X14B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging mandatory maintenance to be carried out.There was no serious patient harm or injury that occurred or was reported.During the evaluation of the device at third-party service center, ventilator inoperative error codes were found in the ventilator's downloaded error log.Evt_mach_flow_drift_high means the machine flow sensor drift above the specification (>0.2lpm) and evt_tpy_held_in_bm means the therapy cpu is still running in boot monitor software.The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the reported error codes.Necessary parts were replaced to fulfill preventive maintenance, and the device passed all testing.Additionally, unrelated to the ventilator inoperative error codes, during the evaluation of the device at third-party service center, error codes related to the motor drive and motor flux measurement were noted.Evt_drv8301_octw_active_low means the motor driver ic has detected an over-current or over-temperature condition.Evt_motor_flux_magnitude_runtime means the motor flux measurement is either too high or too low when the motor is in the run state.Blower assembly needs replacement to address these issues.

• 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: 24484371
• Report Number: 2518422-2026-007308
• Device Sequence Number: 12012785
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: (01)00606959055506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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