BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11606185 · Received April 1, 2021

    Report

    Report Number
    3013095415-2021-00004
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 2, 2021
    Report Date
    March 2, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VENTEC FOR INVESTIGATION. THE REPORTED MALFUNCTION WAS CONFIRMED; HOWEVER VENTEC COULD NOT REPRODUCE IT. THE INVESTIGATION DETERMINED USER ERROR CAUSED/CONTRIBUTED TO THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE UNEXPECTEDLY SHUT DOWN WHILE A PATIENT WAS UNDER TREATMENT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501472 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1