Events

Safety Alert for Newport HT70 and Newport HT70 Plus ventilators

According to National Drugs Administration from El Salvador (DNM), this safety alert involved a device in El Salvador that was produced by manufacturer #8473.

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
  • Event Risk Class
    Class I
  • Date
    2017-04-05
  • Event Country
    El Salvador
  • Event Source
    DNM
  • Event Source URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alerts
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • Extra notes in the data
  • Reason
    The cause of the alert is that reports indicate that the ventilator can spontaneously re-establish itself during normal operation without an alarm indicating it. after restart, the fan enters the standby mode and does not resume ventilation without intervention. inspection was carried out at the distribution company where they stated that only one equipment was used that was used for demonstrations to customers and that to date there had been no sales in el salvador.
  • Action
    Notice to the population recomending not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any pharmaceutical establishment. - Perform search of the product in the BPAs or routine searches. - To find the product in existence within the country, a national alert will be issued.

Device

Newport HT70 and Newport HT70 Plus ventilators

Manufacturer

manufacturer #8473
  • 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
    NDAESDNM