Events

Alerta De Seguridad para CareLink 2090 Programmer

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
    2013-10-07
  • Fecha de publicación del evento
    2013-10-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131007a.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: medtronic carelink 2090 programmer the therapeutic goods administration (tga), australia issued a medical device safety alert concerning carelink 2090 programmer manufactured by medtronic. the affected serial numbers are pkk010877r and pkk054660r. medtronic has identified that a small subset of 2090 programmers have an incorrect software configuration for the country in which that are physically located. when a programmer is manufactured, it is configured for the region in which it will be located. in this way, medtronic is able to differentiate the timing of software updates across different regions of the globe. through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured. medtronic is requesting users to return affected devices for re-configuration. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01024-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 7 october 2013.

Device

CareLink 2090 Programmer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic CareLink 2090 Programmer
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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