BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 11938836 · Received June 4, 2021

    Report

    Report Number
    3013095415-2021-00027
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR AN INVESTIGATION. THE REPORTED EVENT OF UNEXPECTED SHUTDOWN WAS CONFIRMED. THE INVESTIGATION DETERMINED THAT THE STRUTS ON THE COUGH VALVE BROKE, WHICH CAUSED THE UNEXPECTED SHUTDOWN. AFTER REPLACING THE COUGH VALVE, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED WORKING WHILE A PATIENT WAS UNDER TREATMENT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840109 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PRT-00490-001

    Patients

    Seq Age Sex Outcome Treatment
    1