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	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information indicating that during a software update on a trilogy evo device (upgrading from version 1.06.10.00 to 1.06.15.00) displayed a "vent inoperative" message and encountered error e008 (evt_arm_mem_fault_exception).This error occurs when the device reboots three times within a 24-hour period, resulting in a "vent inoperative" state.It is important to note that this issue occurred during the software update.The device was not in patient use.There was no harm or injury reported.The device was returned to a third-party service center for evaluation.The device logs were evaluated, and error code e046 vent service required alarm (evt_internal_batt_not_detected) and e305 vent service required alarm touch screen unresponsive (evt_touchscreen_fail) were discovered.Due to the errors, the printed circuit assembly (pca) was replaced.Additionally, no other problems appeared after replacing the system pca.The particulate filter and air inlet foam filter will need to be replaced.
Additional Manufacturer Narrative
The reported failure of vent inoperable 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.Dhr review was performed for the complaint device serial number, h319925586f3e review confirms that the device met the final acceptance criteria and was released for final distribution.

• 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: 25411478
• Report Number: 2518422-2026-019583
• Device Sequence Number: 9510728
• 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,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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