Events

Alerta De Seguridad para Physio-Control LIFEPAK 15 Monitor/Defibrillator

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

¿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
    2017-02-10
  • Fecha de publicación del evento
    2017-02-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170210.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 15 monitor/defibrillator the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 15 monitor/defibrillator, manufactured by physio-control, with manufacturing dates from 3 september 2014 to 30 june 2016 and distribution dates from 13 september 2014 to 4 july 2016. the manufacturer is recalling the lifepak 15 monitor/defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. if the electrical shock is not delivered, the monitor will indicate “abnormal energy delivery” on the display. a delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. for details, please refer to the following websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm540979.Htm http://www.Physio-control.Com/workarea/downloadasset.Aspx?id=2147498478 according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 february 2017.

Device

Physio-Control LIFEPAK 15 Monitor/Defibrillator
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medical Device Safety Alert: Physio-Control LIFEPAK 15 Monitor/Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

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