Events

Safety Alert for Puritan Bennett 980 Universal Ventilator System

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

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
    2018-03-08
  • Event Date Posted
    2018-03-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180308b.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: medtronic puritan bennett 980 universal ventilator system – tga’s suspension revoked and new suspension in place the therapeutic goods administration (tga) of australia has issued an updated safety alert concerning puritan bennett 980 universal ventilator system, manufactured by medtronic. the original tga’s decision to suspend the pb980 ventilator from the australian register of therapeutic goods (artg), dated 18 september 2017, has been revoked following a review of the decision. however, the review has led to a new decision to suspend the pb980 ventilator from the artg. the suspension is for a period of six months commencing on 5 february 2018. the tga remains concerned that the use of these ventilators has a potential risk of death, serious injury or serious illness. issues that formed the basis for this new suspension were as follows: the current presentation and labelling of the scalar waveform functions of the pb980 ventilator can convey markedly inaccurate values for flow and tidal volume. these values may be different to the ones displayed in the patient data banner; the potential sequelae of relying on those inaccurate flow and tidal volume values as opposed to the values displayed in the patient data banner; and the graphic user interface (gui) is unreliable, because of instances of the screen going blank and the gui becoming unresponsive. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the tga website: http://www.Tga.Gov.Au/alert/puritan-bennet-980-series-ventilator if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 8 march 2018.

Device

Puritan Bennett 980 Universal Ventilator System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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