Company:Covodien.
Date of Enforcement Report:1/9/2014
Class l:
PRODUCT
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG._x000D_ _x000D_ The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014
REASON
Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used on critically ill patients who may not be able to continue breathing without the ventilator. This product may cause serious adverse health consequences, including death.
RECALLING FIRM/MANUFACTURER
Covidien, Boulder, CO 12/16/2013. Voluntary: Firm Initiated recall is ongoing.
FDA District: Denver District
___________________________________
