BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTEC LIFE SYSTEMS, INC.

    MDR report key: 21699554 · Received March 26, 2025

    Report

    Report Number
    3013095415-2025-00230
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 26, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00850018761154
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    H6: VENTEC WILL PERFORM AN EVALUATION OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    H6: VENTEC REACHED OUT TO THE AUTHORIZED SERVICE PROVIDER (ASP) WHO REPORTED THE ISSUE, ASKING WHETHER THE DEVICE HAD BEEN FURTHER EXAMINED/REPAIRED BY THE ASP OR IF IT WILL BE RETURNED TO VENTEC FOR EVALUATION. THE ASP ADVISED THAT THEY INTEND TO RETURN THE DEVICE TO VENTEC FOR AN EVALUATION; HOWEVER, THE ASP WAS NON-COMMITTAL AS TO WHEN IT WOULD BE RETURNED. IF/WHEN THE DEVICE IS EVALUATED BY VENTEC, VENTEC WILL SUBMIT A FOLLOW-UP REPORT AS DEFINED BY 21 CFR 803.56. VENTEC PERFORMED A REVIEW OF THE DEVICE'S MANUFACTURING RECORDS WHICH SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST SPECIFICATIONS WERE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. TREND ANALYSIS AND RISK ANALYSIS WERE CONSIDERED ACCEPTABLE. THE DEVICE WAS NOT RETURNED TO VENTEC FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    AN AUTHORIZED SERVICE PROVIDER (ASP), CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DISPLAYING THE VERY LOW FIO2 (FRACTION OF INSPIRED OXYGEN) ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559229 VENTEC LIFE SYSTEMS, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+PRO, ENGLISH 00850018761154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown