Events

Alerta De Seguridad para m2000sp Instrument

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

¿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
    2011-10-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111013b.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
    Urgent field safety notice: abbott m2000sp instrument medical device manufacturer, abbott molecular, issued an urgent field safety notice concerning m2000sp instrument (list number: 9k14). there have been two reported instances in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated or caught fire. in both cases the event was contained within the lower cabinet of the m2000sp. there were no reported injuries. abbott molecular is actively investigating this issue. according to the local supplier, the affected device has been distributed to hk. abbott molecular recommends users to examine the liquid waste sensor during daily maintenance, and stop using the system when any unusual conditions noticed and contact the local supplier for service. if you are in possession of the affected product, please contact your supplier immediately for necessary actions.

Device

m2000sp Instrument
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott m2000sp Instrument
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH