Events

Edwards Lifesciences Heart Reference Sensor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Edwards Lifesciences 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-2015-RN-00503-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-06-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00503-1
  • 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
    A component of the clearsight system can be damaged if not handled properly. the heart reference sensor (model number evhrs) compensates for pressure differences between the finger cuff and the heart. the finger component of the evhrs may be damaged if subjected to moderate to significant surface impact.
  • 조치
    Edwards Lifesciences is providing work around instructions to assist end users in determining whether the Heart Reference Sensor has been damaged. An insert, included with the recall letter, will be provided with all new EVHRS devices and the Operating Manual of the EV1000NI will be updated on its next release. Edwards Lifesciences is currently working on design changes to avoid the potential for damage to the device and to detect whether damage has been sustained during use. This action has been closed-out on 11/08/2016.

Device

Edwards Lifesciences Heart Reference Sensor

Manufacturer

Edwards Lifesciences Pty Ltd