Alerta De Seguridad para Puritan Bennett 980 Universal Ventilator System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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to suspend the pb980 ventilator from the australian register of therapeutic goods (artg), dated 18 september 2017, has been revoked following a review of the decision.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.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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