BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 21867106 · Received April 18, 2025

    Report

    Report Number
    3013095415-2025-00344
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 18, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007211
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS NOT RETURNED TO VENTEC FOR AN EVALUATION. THE DEVICE WAS FURTHER EVALUATED BY THE AUTHORIZED SERVICE PROVIDER (ASP) WHERE THE REPORTED ISSUES OF IT DELIVERING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) AND DISPLAYING THE VERY LOW FIO2 (FRACTION OF INSPIRED OXYGEN) ALARM WERE CONFIRMED. THE ASP REPLACED THE OAX BOARD (CIRCUIT BOARD) TO RESOLVE THE REPORTED ISSUES. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THE CAUSE OF THE ISSUE TO BE THE OAX BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE DEVICE WAS DELIVERING LOW FIO2 (FRACTION OF INSPIRED OXYGEN). IT WAS ALSO OBSERVED 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
    1680980 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+C+PRO, JAPANESE 00855573007211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown