Events

CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2013-RN-00281-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00281-1
  • 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
    1 - there have been reported cases of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touchscreen) of the cardiohelp device. all manual settings are lost and the system will revert back to the original clinical settings.2 - through internal testing, it has been determined that there is a possibility that electromagnetic interference due to electric current fluctuations may cause pressure valves on the display to "freeze".
  • 조치
    Maquet is providing work around instructions to prevent risk of injury to the patient in the unlikely event of the failure mode occurring during use. Maquet has updated its current CARDIOHELP-i software to version 3.3.2.0 and this will be installed by an authorised Maquet service technician.

Device

CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)
  • 모델명 / 제조번호(시리얼번호)
    CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)Serial Number: All devices up to 90410628 excluding S/N 90410622 and 90410626ARTG Number: 179014
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd