BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 21775406 · Received April 4, 2025

    Report

    Report Number
    3013095415-2025-00270
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 4, 2025
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007822
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS AND CONFIRMED MULTIPLE INSTANCES WHERE IT HAD PREVIOUSLY REBOOTED BY ITSELF, HOWEVER, WHEN THE DEVICE WAS EVALUATED BY VENTEC THE REPORTED ISSUE COULD NOT BE DUPLICATED. VENTEC REPLACED THE INTERNAL FLOW TRANSDUCER (IFT), THE IFT CABLE AND THE CONTROL BOARD TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE IFT, IFT CABLE AND CONTROL BOARD, HOWEVER, FURTHER COMPONENT LEVEL CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON RECEIPT OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR ANALYSIS AND OBSERVED MULTIPLE INSTANCES WHERE IT HAD PREVIOUSLY REBOOTED BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262848 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V*HOME, ENGLISH 00855573007822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown