Events

Recall of Puritan Bennett 980 Series Ventilator System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien Pty Ltd.

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
    RC-2014-RN-01088-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01088-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Normally, if the ventilator is in use and both oxygen and air gas sources are disconnected (leaving the ventilator with no supply of compressed air or oxygen for ventilation of the patient), the ventilator annunciates a high priority “no air supply” and “no o2 supply” alarm. the ventilator then enters a “safety valve open” condition. usually this is immediately recoverable when a gas supply source is reconnected. however, due to a software issue, in some cases the ventilator may transition with a “ventilator inoperative” condition upon reconnection of a gas supply source. during a “ventilator inoperative” condition, the patient is not provided ventilatory support, but may breathe room air spontaneously through the open safety valve. covidien has had no reports of serious patient injury or death associated with this issue.
  • Action
    A Covidien representative will update the software on affected ventilators as soon as possible. Customers may continue to use the ventilators during this time pending the software correction as long as two gas sources are connected to the ventilator at all times. Covidien is also providing important safety reminders in the customer letter which is described in the Puritan Bennett 980 ventilator operator’s manual. This action has been closed-out on 17/08/2016.

Device

Puritan Bennett 980 Series Ventilator System

Manufacturer

Covidien Pty Ltd
  • 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
    DHTGA