Recall Z-2593-2014 ยท CBK Ventilator, Continuous, Facility Use
CareFusion 203, Inc.
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is 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, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are
| Date | Sep 19, 2014 (initiated Aug 8, 2014) |
| Status | Terminated |
| Reason | CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre |
| Root cause | Component design/selection |
| Action | CareFusion sent a Product Recall Notice dated August 8, 2014, to all affected customers. The letter listed the product involved in the recall, described the Issue, Potential Risk , Actions to be Taken by Carefusion, Action to be Taken by the Customer and Other information. Customers were not required to return the devices. Customers were asked to perform the following actions: Once the kit(s) has/have been received, these kits must be fitted and a confirmation must be returned to CareFusion for each kit fitted, identifying the ventilator serial numbers and/or number of AC Power Adapters, Au |
| Quantity | 1729 |
| Distribution | Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI. |
| 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 |