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	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging breathing error detected visible with pneumatic test.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the evaluation of the device at the third-party service center, the error log was checked and an error code related to the oxygen blending module was found.Evt_obm_valve_failure means the o2 proportional valve that controls the flow of o2 to the blower inlet is mechanically stuck closed or open.The oxygen blending module harness needs replaced to address the issue.Also, an error code related to o2 flow was found.Evt_o2_flow_stuck means o2 flow communication ceased and the sensor is reporting the same value.The oxygen blending module subassembly needs replaced to address the issue.Additionally, not related to the reportable error codes, an error code related to the calibration data table was found.Two error codes related to voltage were found.Evt_voltage_3vs3_fail means the 3.3v supply rail exceeded or dropped below threshold due to component tolerance/drift.Evt_voltage_5vs2_fail means the 5v supply rail exceeded or dropped below threshold due to component tolerance/drift.The system board needs replaced to address these issues.Also, an error code related to o2 was found.Evt_o2_pressure_railed_low means the o2 pressure sensor railed to maximum negative value.The oxygen blending module subassembly needs replaced to address the issue.

• 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: 23715459
• Report Number: 2518422-2025-112289
• Device Sequence Number: 16021132
• 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): 12/04/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/04/2025
• 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