Events

Rappel de LUCAS 2 Chest Compression System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00147-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00147-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA