MAUDE Adverse Event Report: Respironics, Inc. LifeVent EVO2; Ventilator, Continuous, Facility Use

Model Number	SP2100X26B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A lifevent evo2 ventilator was returned to a third-party service center following display of a ventilator service required message.There was no allegation of patient harm, and the device was not reported to have been in patient use.During preliminary ¿inprocess¿ evaluation at the third-party service center, the device event log was reviewed and identified error code 81-evt_obm_valve_failure, indicating that the o2 proportional valve, which controls the flow of o2 to the blower inlet, was mechanically stuck closed or open.Error code 149-evt_o2_flow_stuck was also identified, indicating that o2 flow communication had ceased and the sensor was reporting the same value.The technician recommended replacement of the oxygen blender module (obm) to address both critical errors.Additionally, replacement of the obm was expected to address the condition associated with the evt_o2_pressure_railed_low alarm, indicating that the o2 pressure sensor had railed to a maximum negative value.Other errors were also identified during the evaluation; however, they were reported as not requiring attention at this time.No repair had been completed at the time of this report because the customer's approval of the repair quote was pending.A final report is being submitted.If additional information becomes available following completion of the device repair that impacts the investigation findings or medical device reporting determination, a supplemental report will be submitted.
Additional Manufacturer Narrative
The reported failure of device's oxygen blender module (obm) is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Dhr review was performed for the complaint device sn: (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.

• 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 ; +1(724)733-0200
• MDR Report Key: 50882032
• Report Number: 2518422-2026-046329
• Device Sequence Number: 9826573
• 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
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 09/22/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown