Events

Alerta De Seguridad para LIFEPAK CR Plus and LIFEPAK EXPRESS

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

¿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
    2013-03-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20130325.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 alert on two automated external defibrillators the department of health (dh) today (march 22) drew the public's attention to a safety alert issued by an american medical device manufacturer, physio-control inc, on the battery performance of two of its automated external defibrillators (aeds), lifepak cr plus and lifepak express. the dh, through its routine surveillance on medical devices, noticed the above alert from the uk's medicines and healthcare products regulatory agency (mhra). according to the manufacturer, both aeds operate to deliver therapy by battery power. the battery charger is designed to be replaced approximately every two years. however, in some rare situations, the battery charger might experience early internal battery depletion due to an internal electrical failure, resulting in the battery charger lasting less than two years. devices manufactured from 2005 to 2012 are potentially affected by this issue. physio-control inc remarked that the probability of such a failure was extremely remote and the display of the aeds would continue to reflect the device and battery status, even if the device is affected by the issue. "locally, the dh's preliminary enquiries with the local supplier, ids medical systems (hong kong) company limited, revealed that lifepak cr plus has been distributed in hong kong. while the distribution of the potentially affected devices is being confirmed by the supplier, customers are advised to immediately check the readiness of their devices and the battery according to the operating instructions. they should contact their local supplier if a problem is identified. "so far, the dh has not received any relevant report of adverse incidents related to the aeds in hong kong," the spokesman added. the dh has informed public and private hospitals and relevant medical associations about the alert and shall continue to liaise with the supplier on the follow-up actions. ends.

Device

LIFEPAK CR Plus and LIFEPAK EXPRESS
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety alert on two automated external defibrillators
  • Manufacturer
    Physio-Control Inc

Manufacturer

Physio-Control Inc
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH