CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and we

FDA device recall Z-2006-2012 · posted 2012-07-16 · Terminated

Recall details

Recalling firm

CareFusion 203, Inc.

Reason for recall

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 taken

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.

Root cause

Device Design

Status

Terminated

Product code

CBK

Quantity affected

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.

Date initiated

2012-06-19

Date posted

2012-07-16

Date terminated

2013-02-11

Location

Minneapolis, MN

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