Events

Recall of LUCAS 2 Chest Compression System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00147-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00147-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA