Events

HeartWare® Ventricular Assist Systems, model 1407XX, manufactured since September 2014 by HeartWare Inc. 를 위한 리콜 또는 안전성 경고

Agencia Española de Medicamentos y Productos Sanitarios (Via FOI)에 따르면, 해당 리콜 또는 안전성 경고 는 Spain 에서 HeartWare Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Safety Alert
  • 날짜
    2016-06-17
  • 사례 국가
    Spain
  • 사례 출처
    AEMPSVFOI
  • 비고 / 경고
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • 데이터 추가 비고
  • 조치
    Possibility that in HeartWare® Model 1407XX Ventricular Assist Systems, manufactured by HeartWare Inc., United States, the power or data connectors of the controller are released, and may be more vulnerable to damage by water.

Device

HeartWare® Ventricular Assist Systems, model 1407XX, manufactured since September 2014 by HeartWa...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    HeartWare Inc

Manufacturer

HeartWare Inc
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    AEMPSVFOI