Events

Recall of Device Recall Puritan Bennett TM Ventilator System 980 Series

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

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
    79371
  • Event Risk Class
    Class 2
  • Event Number
    Z-1208-2018
  • Event Initiated Date
    2017-11-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162143
  • 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
    Rechargeable lithium-ion batteries with incorrect firmware that are used in certain puritan bennett 980 ventilators may not fully charge after installation.
  • Action
    Consignees are instructed to immediately notify all care environments in which the PB980 ventilators are used about the notification. If the facility has distributed PB980 ventilators to other persons or facilities, they are asked to please promptly forward a copy of the letter to those recipients. The consignee is asked to complete an attached form and return it as directed to confirm receipt and understanding of the notification.The firm developed a tool to inspect and identify the firmware on the batteries. Medtronic service engineers will inspect batteries at consignee facilities during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced. For further questions, please call (203) 492-5415.

Device

Device Recall Puritan Bennett TM Ventilator System 980 Series
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam
  • Product Description
    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 || The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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