BEUDAMED
    FDA Recall Terminated

    CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

    Recall: Z-2006-2012 · Initiated June 19, 2012

    Recall

    Recall Number
    Z-2006-2012
    Event Number
    62349
    FEI Number
    3002617992
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 19, 2012
    Posted
    July 16, 2012
    Terminated
    February 11, 2013
    Address
    17400 Medina Rd CareFusion 203, Inc. Ste 100, Minneapolis, MN, 55447-1341

    Description

    CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

    Reason

    CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.

    Action

    CareFusion sent an Urgent Product Recall letter with a return receipt dated June 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required Action for Users: If the ventilator resumes normal ventilation (intermittent leak) the audible alarm stops. To clear the alarm indicator on the ventilator display, enter Alarm Messages tab, push alarm Reset to clear display. If the ventilator does not resume normal ventilation (continuous leak) provde an alternative method of ventilation to the patient. CareFusion will follow-up with a phone call to coordinate the correction of the devices. For questions customers should call 1-800-554-8933.

    Distribution

    Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV.

    Quantity

    266