Events

Alerta De Seguridad para physio-control lifepak cr plus and lifepak express automated external defibrillators

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
    2016-07-06
  • Fecha de publicación del evento
    2016-07-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160706.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: physio-control lifepak cr plus and lifepak express automated external defibrillators the food and drug administration (fda) of the united states posted a medical device safety alert concerning lifepak cr plus and lifepak express automated external defibrillators (aed), manufactured by physio-control inc. the affected aeds may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. according to the manufacturer, a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. for details, please refer to the fda enforcement report website: http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm (recall number: z-2100-2016) if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 july 2016.

Device

physio-control lifepak cr plus and lifepak express automated external defibrillators
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators
  • Manufacturer
    Physio-Control Inc

Manufacturer

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