Events

Recall of Puritan Bennett 980 Series Ventilator System PB980

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-2016-RN-00089-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00089-1
  • 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
    There have been reports of issues with the graphical user interface (gui) & loss of primary ventilation. the gui can become unresponsive to touch, but the ventilator continues to operate at existing settings, all real-time waveforms, pressure/volume measurements, alarm functions & the bezel keys remain active. however, users are unable to change ventilator settings/configuration of the display. plus, under certain circumstances there is a loss of primary ventilation capabilities, in which the backup ventilation (buv) design feature is activated. when buv is initiated, high urgency audio & visual alarms are enunciated immediately & cannot be silenced. in some cases, the ventilator subsequently progressed to a ventilator inoperative condition, where the ventilator opens all valves to atmospheric pressure & room air, & ventilation ceases. high urgency audio/visual alarms are enunciated. there have been no reports of adverse health effects or death associated with the above situations.
  • Action
    Covidien is advising users that the continued use of the affected devices is appropriate. However, the decision to continue to use the affected devices should be made in the context of the individual patient’s clinical condition. If the reported defects occur, the clinical team should transfer the patient to anther ventilator. The manufacturer is working on a service update which will be implemented as soon as it becomes available.

Device

Puritan Bennett 980 Series Ventilator System PB980

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