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

Model Number	SP2100X26B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator service required alarm involving the internal battery occurred.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 lifevent evo2 was returned to the third-party service center and device evaluation completed on 24 july 2025 with the following findings: the alleged device error code e-059 was found on the device but was not able to be reproduced during evaluation and testing.This ventilator service required code indicates the internal or detachable li-ion battery is not charging due to a hardware fault for greater than, or equal to, one minute.The unit arrived for evaluation with no detachable battery.While testing the unit with a detachable battery attached, the error code e-59 could not be reproduced.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.Additional findings not related to the malfunction/issue: one in-line filter was noted to be contaminated and required replacement.The air inlet foam filter is replaced due to preventative maintenance.

• 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: 20370717
• Report Number: 2518422-2024-101552
• Device Sequence Number: 6859799
• 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): 09/16/2025

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
• Operator of Device: Other
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2020
• 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