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); Battery Problem (2885); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported internal battery not detected error 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.The reported pressure sensor mismatch error is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of 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.
Event or Problem Description
The manufacturer received information alleging a maintenance required alarm occurred on a garbin evo / trilogy evo ventilator.There was no serious patient harm or injury that occurred or was reported.During the evaluation at the third-party service center, two ventilator service required error codes were found in the device's error log relating to 'internal battery not detected' and 'pressure sensor mismatch.' the service technician states that the pressure sensor mismatch error was caused by contamination.The machine flow sensor, blower chass tubing, fio2 tubing, low flow o2 tubing, and system printed circuit assembly (pca) board tubing were contaminated with dust and were replaced to resolve the error.There is no documentation stated on a root cause and/or any component replacement to resolve the internal battery not detected error.Additionally, the dc harness assembly and warning label were damaged.The connector cover was missing.The air inlet foam filter and particulate filter were replaced for maintenance.And a pm label was added to the unit.

• 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: 24880111
• Report Number: 2518422-2026-010862
• Device Sequence Number: 13220301
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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
• Operator of Device: Other
• Device Model Number: LD2110X23B
• Device Catalogue Number: LD2110X23B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/14/2026
• 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