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

Model Number	LD2110X23B
Medical Device Problem Codes	Contamination (1120); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A garbin evo was returned to a third-party service center for service, with an allegation of maintenance required.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During evaluation of the trilogy evo by the third-party service center, an error code related to pressure was found in the error log.Evt_press_sensor_mismatch means the device software has detected a large pressure drop between the monitor and outlet pressure sensors (i.E.Across the machine flow sensor).The device's machine flow sensor was replaced due to dust contamination.

• Brand Name: GARBIN EVO, LINDE
• 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: 24688455
• Report Number: 2518422-2026-010002
• Device Sequence Number: 10004210
• Product Code: CBK
• UDI-Device Identifier: 00606959057432
• UDI-Public: (01)00606959057432
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/25/2026

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: LD2110X23B
• Device Catalogue Number: LD2110X23B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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