Events

Recall of Device Recall Puritan Bennett 840 Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett Inc. (dba Covidien LP).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68444
  • Event Risk Class
    Class 2
  • Event Number
    Z-1844-2014
  • Event Initiated Date
    2014-06-03
  • Event Date Posted
    2014-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127717
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • 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.
  • 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 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.

Device

Device Recall Puritan Bennett 840 Ventilator
  • Model / Serial
    serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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, 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
  • Product Description
    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.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA