Events

Safety Alert for Puritan Bennett 980 series Universal ventilator system

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Covidien.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-07-23
  • Event Date Posted
    2015-07-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150723_1.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: covidien puritan bennett 980 series universal ventilator system the therapeutic goods administration (tga) of australia posted a medical device safety alert concerning the neonatal applications (neomode software) in puritan bennett 980 series (pb980) universal ventilator system manufactured by covidien. pb980 universal model ventilator is designed for neonatal, paediatric and adult patients. according to the manufacturer, there have been reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (vc+) mode with active humidification. this situation may potentially lead to respiratory compromise if not recognized. the manufacturer will develop and implement a software update for the universal models of ventilators with neomode capability. for details, please refer to the following tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00676-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 july 2015.

Device

Puritan Bennett 980 series Universal ventilator system
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Medical Device Safety Alert: Covidien Puritan Bennett 980 series Universal ventilator system
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 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
    DH