BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 15385877 · Received September 8, 2022

    Report

    Report Number
    3013095415-2022-00726
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    May 11, 2022
    Report Date
    August 18, 2022
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY VENTEC AND ITS ELECTRONIC RECORDS WERE DOWNLOADED FOR ANALYSIS. VENTEC OBSERVED THAT IT HAD PREVIOUSLY ALARMED DUE TO LOW INSPIRATORY PRESSURE. VENTEC REPLACED THE EXTERNAL FLOW MODULE (EFM) TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS THEN CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUE WAS THE EFM.

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED THEIR DEVICE TO VENTEC FOR SERVICE. DURING THE DEVICE'S EVALUATION, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS FOR ANALYSIS WHERE IT WAS OBSERVED THAT IT HAD PREVIOUSLY ALARMED DUE TO LOW INSPIRATORY PRESSURE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2096731 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown