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	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging necessary assistance.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, error codes related to o2 were observed.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.Evt_o2_flow_railed_low means the o2 flow sensor railed to maximum negative value.Evt_o2_flow_stuck means the o2 flow communication ceased and the sensor is reporting the same value.The oxygen blending module needs to be replaced to address these issues.Additionally, non-reportable error codes were observed.Evt_o2_pressure_railed_low means the o2 pressure sensor railed to maximum negative value.Evt_model_num_obm_mismatch means a ventilator that is given a model number to have an obm does not have one installed when it should be.The oxygen blending module needs to be replaced to address these issues.Evt_out_press_railed_low means the outlet pressure sensor railed to maximum negative value.Evt_mon_press_railed_low means the monitor pressure sensor railed to maximum negative value.Evt_voltage_3vs4_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 to be replaced to address these issues.

• 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: 23716148
• Report Number: 2518422-2025-112293
• Device Sequence Number: 21393511
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/04/2025
• 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