Events

Alerta De Seguridad para Photon DR (Model V-230HV), Photon Micro VR/DR (Models V-194/V-232), Atlas VR/DR (Models V-199/V-240)

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
    2005-10-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20051010.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
    Press release
  • Causa
    Safety information regarding st. jude medical implantable cardioverter defibrillators 10 october 2005 the department of health was notified today by the manufacturer of several older generation implantable cardioverter defibrillators that some of its products may be affected by cosmic rays and may not function properly. according to st. jude medical (hong kong) ltd., the affected models are: photon dr (model v-230hv) (certain serial numbers) photon micro vr/dr (models v-194/v-232) atlas vr/dr (models v-199/v-240) no serious patient injury or death has been reported so far. there are totally 34 patients implanted with the affected devices through the public hospitals in hong kong. the supplier has advised the hospital authority of this matter. all the affected patients will be informed by their doctors for follow up actions shortly.

Device

Photon DR (Model V-230HV), Photon Micro VR/DR (Models V-194/V-232), Atlas VR/DR (Models V-199/V-240)
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety Information regarding St. Jude Medical Implantable Cardioverter Defibrillators
  • 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