Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-inva

FDA device recall Z-1844-2014 · posted 2014-06-20 · Terminated

Recall details

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Reason for recall

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.

Action taken

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 process to receive the actions mentioned above, please complete the attached verification form and fax it to the Covidien contact indicated on the form. If you need further assistance, contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CBK

Quantity affected

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

Date initiated

2014-06-03

Date posted

2014-06-20

Date terminated

2016-08-22

Location

Boulder, CO

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