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

Model Number	SP2100X26B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Insufficient Device Problem Information (3190)
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
The manufacturer received information alleging a lifevent evo2 ventilator is in an inoperative condition.There was no harm or injury reported.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The device was returned to a third-party service center and evaluation of the allegation that the device was no operational was completed with the following findings: the device experienced a ventilator inoperative condition evidenced by device error code e-155 which indicates the machine flow sensor drift was above specification.The devices machine flow sensor required replacement to address this issue.Additional findings not related to the malfunction/issue: a non-critical device event code occurred indicating the sensor offset during drift calculation was too high and required the replacement of the system printed circuit board assembly.A non-critical device event code occurred indicating the motor controller had proceeded to the shutdown state due to an error with the motor and required replacement of the blower due to being defective.In-line proximal filter and inlet foam filter were replaced due to preventative maintenance.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: 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: 22077481
• Report Number: 2518422-2025-106003
• Device Sequence Number: 9374423
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• 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