Events

LUCAS 2 Chest Compression System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00147-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00147-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA