Recall Z-1844-2014 ยท CBK Ventilator, Continuous, Facility Use
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
| Date | Jun 20, 2014 (initiated Jun 3, 2014) |
| Status | Terminated |
| Reason | Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support. |
| Root cause | Nonconforming Material/Component |
| Action | Covidien sent an Urgent Medical Device Voluntary Field Correction letter dated 6/13/2014, to all affected customers. The letter identified the product the problem and and the action needed to be taken by the customer. Customers are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Service professionals will be identifying the affected PSUs and replacing them. The removed PSUs will be destroyed. To verify whether your devices are affected by this field safety corrective action and to initiate the proc |
| Quantity | 104 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and the countries of Argentina, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp., Apr 30, 1998 |