Events

Alerte De Sécurité sur Newport HT70 and Newport HT70 Plus ventilators

Selon National Drugs Administration from El Salvador (DNM), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à El Salvador qui a été fabriqué par manufacturer #8473.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Classe de risque de l'événement
    Class I
  • Date
    2017-04-05
  • Pays de l'événement
    El Salvador
  • Source de l'événement
    DNM
  • URL de la source de l'événement
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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