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

Model Number	LD2110X23B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a garbin evo ventilator was returned to a third-party service center due to maintenance required.There was no patient involvement, and no harm or injury reported.On device evaluation, a ventilator inoperative code e-155 had occurred indicating the machine flow sensor drift above the specification and requiring replacement of the machine flow sensor to address the issue.Four-year preventative maintenance was completed.Additional findings not related to the malfunction/issue: a non-critical device event code e-144 was noted in the device error log indicating the motor controller has proceeded to the shutdown state due to an error with the motor and requiring replacement of the blower.A non-critical event code e-300 was noted in the device error log indicating the sensor offset during drift calculation is too high and requiring replacement of the system printed circuit board assembly to resolve.The blower bellows, tubing fio2 and tubing low flow o2 were contaminated with dirt.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 and associated medical device reporting 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: 24639844
• Report Number: 2518422-2026-009768
• Device Sequence Number: 9842379
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2021
• 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