Events

CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG Number: 179104 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-00946-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-09-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00946-1
  • 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
    Maquet cardiopulmonary has determined that in certain rare instances the cardiohelp-i device may display an error message with audible alarm indicating "battery defective". the alarm will occur while booting or when the main power supply is unplugged from the main power source. this is due to a defective capacitor within the battery manager board. further, when alarming the hmi (human machine interface) will gradually become black due to the hmi back light shutting down.
  • 조치
    Maquet is advising the customers to only use the Cardiohelp-I on AC power when possible. In the event of a battery defect alarm the AC power should be connected immediately. An upgrade to the sensor panel will be carried out to correct the issue.

Device

CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG...
  • 모델명 / 제조번호(시리얼번호)
    CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG Number: 179104
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd