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
    2017-09-19
  • Event Date Posted
    2017-09-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170919b.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 the therapeutic goods administration (tga) of australia has issued a safety alert concerning puritan bennett 980 universal ventilator system, manufactured by medtronic. consumers and health professionals are advised that the tga has suspended the covidien/medtronic pb980 ventilator from the australian register of therapeutic goods (artg) for six months. this action has been taken as the tga is concerned that, until rectified, use of these ventilators raises a potential risk of death, serious injury or illness. pb980 ventilators provide respiratory support to patients in intensive care units or other high-level care wards within hospitals and during intra-hospital transport. these ventilators have been the subject of several complaints relating to the screen going blank, graphical user interface (gui) becoming unresponsive, unexpected shutdowns or restarts, false triggering, serial number mismatch and usb failures. additionally, the manufacturer has identified issues with accuracy when used with newborn infants (neomode). some of these issues had been progressively addressed in a series of software updates during 2015 and 2016. however, further incident reports were received subsequently and testing by tga laboratories in 2017 found a range of serious issues persisted. the tga sought expert advice from the advisory committee on medical devices (acmd) regarding the clinical risk of the accuracy of ventilation observed by the tga's laboratories, the clinical risk of the issues with the device's user interface, and the safety of the performance specifications published in the operator's manual. following its meeting on 24 august 2017, acmd advised the tga that: the issues with the user interface, including the loss of interactivity with control settings, which were observed by the tga laboratories and in device incident reports, were an unacceptable risk to patients for a device intended to be used in a critical care environment. the discrepancies in ventilation accuracy observed by the tga laboratories were an unacceptable risk to paediatric patients. the tolerances for variation in ventilation therapy that are reported in the operator's manual were not suitable for paediatric patients. in addition, the committee believed it would be difficult to set conditions under which the use of this device may be safe for paediatric patients, that is a patient weighing less than 35 kg. the tga has notified state and territory health authorities, private hospitals and clinics of the decision to suspend the device from the register. tga recommends that health professionals consider not using the device where suitable alternatives are available. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the tga website: https://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 19 september 2017.

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