Events

Alerta De Seguridad para Puritan Bennett 980 series Universal ventilator system

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

¿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
    2015-07-23
  • Fecha de publicación del evento
    2015-07-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150723_1.html
  • 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: covidien puritan bennett 980 series universal ventilator system the therapeutic goods administration (tga) of australia posted a medical device safety alert concerning the neonatal applications (neomode software) in puritan bennett 980 series (pb980) universal ventilator system manufactured by covidien. pb980 universal model ventilator is designed for neonatal, paediatric and adult patients. according to the manufacturer, there have been reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal volume control plus (vc+) mode with active humidification. this situation may potentially lead to respiratory compromise if not recognized. the manufacturer will develop and implement a software update for the universal models of ventilators with neomode capability. for details, please refer to the following tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00676-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 july 2015.

Device

Puritan Bennett 980 series Universal ventilator system
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Covidien Puritan Bennett 980 series Universal ventilator system
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    DH