BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVENT EVO2

    MDR report key: 22090244 · Received May 27, 2025

    Report

    Report Number
    2518422-2025-106081
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 23, 2025
    Report Date
    June 11, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959057456
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIFEVENT EVO2 (104426748) IS SUBSTANTIALLY SIMILAR TO THE TRILOGY EVO O2 (100853034) AND WILL BE REPORTED IN THE UNITED STATES UNDER TRILOGY EVO O2, 501K NUMBER: K181166.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "FAN NOT OPERATIONAL" CONDITION HAD OCCURRED ON A LIFEVENT EVO2 DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE THIRD-PARTY SERVICE TECHNICIAN CONFIRMED THE CUSTOMER¿S ISSUE AND OBSERVED ERROR CODES MOTOR FAILURE IN THE DEVICE¿S EVENT LOG. THE THIRD-PARTY SERVICE TECHNICIAN REPLACED THE DEVICE'S MACHINE FLOW SENSOR TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS THE THIRD-PARTY SERVICE TECHNICIAN FINDING ADDITIONAL SYSTEM ERRORS FOR THERAPY BUZZER FAILURE, POWER BUZZER FAILURE, DRIFT DEBUG, AND MOTOR CONTROLLER SHUTDOWN. THE THIRD-PARTY SERVICE TECHNICIAN REPLACED THE BUZZER ASSEMBLY, AND THE SYSTEM PRINTED CIRCUIT ASSEMBLY BOARD TO ADDRESS THESE ISSUES. THE THIRD-PARTY SERVICE TECHNICIAN PROACTIVELY REPLACED THE AIR INLET FOAM FILTER ON THE DEVICE. AFTER REPLACING ALL OF THESE PARTS ON THE DEVICE, THE THIRD-PARTY SERVICE TECHNICIAN PERFORMED THE FUNCTIONAL TEST, AND THE DEVICE PASSED IT. THE THIRD-PARTY SERVICE TECHNICIAN FOUND THE DEVICE OPERATIONAL.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "FAN NOT OPERATIONAL" CONDITION HAD OCCURRED ON A LIFEVENT EVO2 DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329768 LIFEVENT EVO2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. SP2100X26B 00606959057456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown