MAUDE Adverse Event Report: RESPIRONICS, INC. LIFEVENT EVO2; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	SP2100X26B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo ventilator was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center, "service required" codes e-147 and e-149 were found in the ventilator's downloaded error log indicating the o2 flow sensor railed to maximum negative value and o2 flow communication ceased and the sensor is reporting the same value.The device's oxygen blending module board assembly required replacement to address the issue.After repair, the device passed final testing and was confirmed to be operating properly.

• Brand Name: LIFEVENT EVO2
• 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: 22382397
• Report Number: 2518422-2025-107011
• Device Sequence Number: 9417950
• Product Code: CBK
• UDI-Device Identifier: 00606959057456
• UDI-Public: (01)00606959057456
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: SP2100X26B
• Device Catalogue Number: SP2100X26B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2020
• 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