Events

Alerta De Seguridad para Merlin@Home Transmitter

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

¿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
    2012-06-27
  • Fecha de publicación del evento
    2012-06-27
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120627.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: st.Jude medical merlin@home transmitter the health canada posted a medical device recall notice concerning merlin@home transmitter, manufactured by st. jude medical, cardiac rhythm management system. the affected model number is ex1150. according to the manufacturer, there is potential for intermittent communication difficulties with these merlin@home transmitters due to an anomaly with a microcontroller chip in the transmitter. if the anomaly occurs, the patient's merlin@home transmitter will not be able to send data to the merlin.Net database. however, implanted device function is not affected. for details, please refer to health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 jun 2012.

Device

Merlin@Home Transmitter
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: St. Jude Medical Merlin@Home Transmitter
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • 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