BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11864213 · Received May 21, 2021

    Report

    Report Number
    3013095415-2021-00025
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE DEVICE WAS RETURNED FOR AN EVALUATION. VENTEC PERFORMED AN EVALUATION OF THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    VENTEC HAS NOT PERFORMED AN EVALUATION ON THE DEVICE YET, A CONCLUSION IS NOT YET AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO VENTILATE WHILE A PATIENT WAS UNDER TREATMENT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761416 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1