Events

Recall of Device Recall Puritan Bennett 840 ventilator systems software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien.

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
    67108
  • Event Risk Class
    Class 1
  • Event Number
    Z-0611-2014
  • Event Initiated Date
    2013-12-16
  • Event Date Posted
    2014-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124713
  • 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 voluntary field corrective action on puritan bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code xb0069 in which the device stops mechanical ventilation due to a software error.
  • Action
    Covidien sent an Urgent Medical Device Voluntary Field Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue using their Puritan Bennett 840 ventilators until it is feasible to install the software update discussed in the letter. Covidien has developed a software solution to address this issue. Upon availability, there will be several ways to install the software update. To initiate the process for updating your software and to select the method that best suits your facility, please visit our software update management portal at www.PB840technicalupdate.com and follow the instructions to register your ventilators. If you need further assistance contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1. For questions regarding this recall call 800-255-6774.

Device

Device Recall Puritan Bennett 840 ventilator systems software
  • Model / Serial
    Software Part number 4-070212-85, revision AB-AG
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Austria, Estonia, Belgium, Spain, Italy, Poland, Bulgaria, Finland, Portugal, Switzerland, France, Lithuania, Romania, Cyprus, Great Britain, Czech Republic, Greece, Latvia, Slovenia, Germany, Hungary, Slovak Republic, Ireland, Netherlands, Turkey, Croatia, Andorra, Albania, Algeria, Bahrain, Bosnia and Herzegovina, Egypt, Georgia, Iran, Iraq, Israel, Jordan, Kenya, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Morocco, Russia, Saudi Arabia, Serbia, South Africa, Syria, Sudan, Tunisia, UAE, Uganda, Puerto Rico, Mexico, Columbia, Chile, Brazil, Argentina, Uruguay, Panama, Costa Rica, Peru, China, Korea, Japan, Taiwan, Hong Kong, Malaysia, Singapore, Sri Lanka, Australia, New Zealand.
  • Product Description
    Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. || The intended use of the product is to provide mechanical ventilation to patients.
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Manufacturer Address
    Covidien, 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