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

Model Number	LD2110X23B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a garbin evo ventilator required maintenance.There was no serious patient harm or injury that occurred or was reported.The ventilator was returned to a third-party service center for evaluation.The device log files were successfully downloaded and reviewed in full.Log review confirmed the occurrence of a ¿ventilator inoperative¿ alarm related to the machine flow sensor.This error indicates that the machine flow sensor drifted above specification (>0.2 lpm).The machine flow sensor needs to be replaced to address the issue.Additionally, findings unrelated to the reported malfunction were identified.The blower requires replacement due to an alarm indicating the motor controller has proceeded to the shutdown state due to an error with the motor.The system printed circuit assembly (pca) needs to be replaced due to an error indicating that the sensor offset during drift calculation was too high.As part of routine preventive maintenance, the air inlet foam filter, muffler assembly, and particulate filter need to be replaced.Additionally, the in-line filter and proximal filter were contaminated with dust.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation, a follow up/supplemental report will be completed.

• 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: 24674030
• Report Number: 2518422-2026-009928
• Device Sequence Number: 10149250
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2020
• 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