BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11787890 · Received May 6, 2021

    Report

    Report Number
    3013095415-2021-00019
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 7, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VENTEC FOR INVESTIGATION. THE REPORTED MALFUNCTION WAS CONFIRMED. THE INVESTIGATION DETERMINED USER ERROR CAUSED/CONTRIBUTED TO THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THE DEVICE UNEXPECTEDLY SHUT DOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684032 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-01100-000

    Patients

    Seq Age Sex Outcome Treatment
    1