Events

Retiro De Equipo (Recall) de LUCAS 2 Chest Compression System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00147-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00147-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Stryker 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; or ·the device does not temporarily stop and lock in the start position when the pause button is pressed.
  • Acción
    A Stryker Technical Operations representative will be in contact with users upon receipt of the form supplied with the Customer Letter to arrange for replacement of an internal cable. Users are advised to refer to Sections 3.8 and 5.4 of the IFU 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.

Device

LUCAS 2 Chest Compression System
  • Modelo / Serial
    LUCAS 2 Chest Compression System Item Number : 3302430-145Multiple Affected Serial NumbersManufactured between September 2014 and April 2015ARTG Number: 121182Stryker Australia Pty Ltd - Resuscitator, cardiac, electrically-powered
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA