Events

Recall of Device Recall Puritan Bennett 980 Ventilator System

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

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
    73096
  • Event Risk Class
    Class 2
  • Event Number
    Z-1181-2016
  • Event Initiated Date
    2016-01-15
  • Event Date Posted
    2016-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143047
  • 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
    Graphical user interface (gui) unresponsive to touch and loss of primary ventilation under certain circumstances. covidien respiratory and monitoring solutions, now a part of medtronic, issued a field corrective action notice for two issues on all models of puritan bennett 980 (pb980) ventilator.
  • Action
    Customers were notified via an Urgent Medical Device Safety Notification, dated February 8, 2016, on 1/14/16. The letter identified the affected device and the issues involved. Consignees are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Medtronic is investigating the root cause of these conditions and will provide a service update to resolve the issues as soon as corrections can be implemented. Customers are to complete the attached form and return it per the instructions to confirm receipt and understanding of the information. Questions or issues should be directed to the Technical Support Department at 800-255-6774.

Device

Device Recall Puritan Bennett 980 Ventilator System
  • Model / Serial
    all versions of software.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.
  • Product Description
    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). || Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
  • Manufacturer
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Manufacturer

Covidien LP (formerly Nellcor Puritan Bennett Inc.)
  • Manufacturer Address
    Covidien LP (formerly Nellcor Puritan Bennett Inc.), 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