BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 6214723 · Received December 29, 2016

    Report

    Report Number
    2021710-2016-05151
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 2, 2016
    Report Date
    January 24, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS INTERMITTENTLY ALARMING MOTOR FAULT AND VENT INOPERABLE. PATIENT INVOLVEMENT IS UNKNOWN AS ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS INTERMITTENTLY ALARMING MOTOR FAULT, TRANSDUCER FAULT, AND VENT INOPERABLE. THE ISSUE OCCURRED DURING PATIENT USE BUT THERE WAS NO HARM TO THE PATIENT AS THE PATIENT WAS SWITCHED TO ALTERNATE VENTILATION. THIS ISSUE WAS REPORTED TO HAVE OCCURRED ON MULTIPLE VENTILATORS DURING PATIENT USE BUT THE CUSTOMER DOES NOT HAVE ANY DETAILS ABOUT THESE PARTICULAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864916 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention