Events

Alerta De Seguridad para LUCAS 2 Chest Compression System

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

¿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
    2018-02-23
  • Fecha de publicación del evento
    2018-02-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180223b.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: jolife ab lucas 2 chest compression system the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning lucas 2 chest compression system [item number: 3302430-145; multiple affected serial numbers; manufactured between september 2014 and april 2015], manufactured by jolife ab. the manufacturer has become aware of a potential reliability issue where the lucas device may not respond to the push of certain buttons due to potential damage of an internal cable. the user control panel cable can be damaged by rubbing against an adjacent cable connector. if the malfunction were to occur, it may cause the device to exhibit one of the following: the device does not change from one active mode to the other the device does not begin compressions the device does not temporarily stop and lock in the start position when the pause button is pressed the manufacturer will arrange for replacement of an internal cable. users are advised to refer to sections 3.8 and 5.4 of the instruction for use, which states that if there are interruptions, if the compressions are not sufficient, or something unusual occurs during operation: push on/off for 1 second to stop lucas and remove the device from the patient. immediately start manual chest compressions. for details, please refer to the tga’s website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00147-1 posted on 23 february 2018.

Device

LUCAS 2 Chest Compression System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Jolife AB LUCAS 2 Chest Compression System
  • Manufacturer
    Jolife AB

Manufacturer

Jolife AB
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH