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Recall Observatory FDA recall evidence

Device product

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.

Z-1844-2014

June 03, 2014

Class II

Product summary

Firm
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Event
Event 68444
Status
Terminated
Classification
Class II
Quantity
104
Official record key
device-enforcement:Z-1844-2014

Official wording

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.

Code information: serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.

Distribution pattern: 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, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, Germany, Guatemala, Israel, Japan, Kazakhstan, Kenya, Lebanon, Libya, Macedonia, Mexico, Montenegro, Morocco, Panama, Peru, Russia, Saudi Arabia, Singapore, Switzerland, Taiwan, Tunisia, Turkey, Yugoslavia (Serbia & Montenegro) Including GOVT/VA/Military

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.