Recall Z-2006-2012 ยท CBK Ventilator, Continuous, Facility Use
CareFusion 203, Inc.
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.
| Date | Jul 16, 2012 (initiated Jun 19, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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 fo |
| Quantity | 266 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 Pulmonetic Systems, Inc., Aug 1, 2007 |