BEUDAMED
    FDA Enforcement Class I 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 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2006-2012
    Event ID
    62349
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 203, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    June 19, 2012
    Classification Date
    July 16, 2012
    Termination Date
    February 11, 2013
    Address
    17400 Medina Rd Ste 100, Minneapolis, MN, 55447-1341, United States

    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.

    Code Info

    serial numbers: 26562, 43634, 43642, 43643, 44536, 44537, 44540, 44541, 44542, 44543, 44544, 44545, 44546, 44552, 44553, 44554, 44555, 44557, 44558, 44559, 44560, 44561, 44562, 44563, 44564, 44565, 45318, 45320, 45321, 45322, 45323, 45324, 45325, 45326, 45327, 45328, 45329, 45330, 45333, 45334, 45335, 45336, 45337, 45338, 45339, 45340, 45341, 45342, 45343, 45344, 45345, 45346, 45735, 45736, 45737, 45738, 45739, 45740, 45741, 45742, 45743, 45744, 45745, 45746, 45748, 45750, 45751, 45752, 45753, 45754, 45902, 45903, 45904, 45905, 45906, 45907, 45908, 45909, 45910, 45911, 46038, 46039, 46040, 46041, 46042, 46043, 46044, 46045, 46046, 46047, 46048, 46049, 46050, 46051, 46052, 46632, 46634, 46635, 46636, 46637, 46638, 46639, 46640, 46641, 46642, 46643, 46644, 46645, 47069, 47070, 47071, 47073, 47074, 47075, 47076, 47077, 47078, 47079, 47080, 47081, 47082, 47083, 47210, 47211, 47212, 47213, 47214, 47215, 47216, 47217, 47219, 47221, 47222, 47223, 47225, 47226, 47227, 47229, 47230, 47231, 47232, 47233, 47234, 47236, 47237, 47238, 47239, 47538, 47539, 47540, 47541, 47542, 47543, 47544, 47545, 47546, 47547, 47548, 47549, 47550, 47551, 47552, 47553, 47554, 47555, 47556, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47565, 47566, 47567, 48759, 48760, 48761, 48762, 48763, 48764, 48765, 48766, 48767, 48768, 48769, 48770, 48771, 48772, 48773, 48774, 48775, 48776, 48777, 48778, 48779, 48780, 48781, 48782, 48783, 48784, 48785, 48786, 48787, 48788, 48868, 48869, 48870, 48871, 48872, 48873, 48874, 48875, 48876, 48878, 48881, 48883, 48884, 48885, 48886, 48887, 48889, 48890, 48891, 48892, 48893, 48894, 48895, 48897, 50390, 50391, 50392, 50393, 50394, 50395, 50397, 50409, 50411, 50412, 50416, 50417, 50418, 50419, 50648, 50650, 50651, 50652, 50654, 50656, 50657, 50658, 50659, 50660, 50661, 50662, 50663, 50664, 50665, 50666, 50667, 50668, 50672, 51569, 51574

    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