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

Model Number	LD2110X23B
Medical Device Problem Codes	Circuit Failure (1089); 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, ventilator inoperative device error code e-155 was noted in the device error log indicating the machine flow sensor drift was above the specification.Replacement of the machine flow sensor is required to resolve the issue.Additional findings not related to the malfunction/issue: the machine flow sensor, blower and proximal filters were contaminated with dust and require replacement.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.
Additional Manufacturer Narrative
Additional information received from device evaluation on 19 march 2026 stated in relation to the previously reported device error code that occurred indication the machine flow sensor drift was above the specification, the evaluation found the machine flow sensor was contaminated with dust as well as the blower and proximal filters, all of which require replacement for the issue.
Additional Manufacturer Narrative
Information received from the third-party service center reporting the findings from the completed device evaluation.On final evaluation, based on device error code e-155 indicating the machine flow sensor drift was above the specification, it was determined the system printed circuit board assembly required replacement to address the ventilator inoperative issue.The machine flow sensor, blower and blower bellows did not require replacement.Additional findings not related to the malfunction/issue: the proximal filters were contaminated with dust and required replacement.The coding grids have been updated to reflect this final device evaluation result.The reported failure of a ventilator inoperative alarm indicating a machine flow sensor issue 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.

• 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: 24639193
• Report Number: 2518422-2026-009764
• Device Sequence Number: 18591220
• 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,Followup,Followup
• Report Date (Section B): 04/21/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 03/19/2026; Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/25/2026; 04/21/2026
• 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