Maquet/Datascope Intra-Aortic Balloon Pump (IABP) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-2017-RN-00991-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-07
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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/getinge has received complaints involving the cs100/cs100i and cs300 iabps regarding the following issues:1. false blood detection alarm; and2. the ingress of fluids into the iabp affecting various electronic circuit boards.No serious injuries to patients have been reported as of august 2017.
  • 조치
    Each affected facility will be contacted by a representative of the Getinge Service Team to schedule on-site service of the CS100/CS100i or CS300 IABP

Device

  • 모델명 / 제조번호(시리얼번호)
    Maquet/Datascope Intra-Aortic Balloon Pump (IABP)Product Numbers: CS100i IABP, CS100 IABP, CS300 IABPPart Numbers: 0998-UC-0446HXX, 0998-UC-0479HXX, 0998-00-3013-XX, 0998-UC-3013-XX, 0998-00-3023-XX, 0998-UC-3023-XXARTG Number: 118266
  • Manufacturer

Manufacturer