Inspiration LS, and i Series Ventilator Systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 eVent Medical 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
    Safety alert
  • 날짜
    2015-10-20
  • 사례 출판 날짜
    2015-10-20
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: event medical inspiration ls, and i series ventilator systems the medicines and healthcare products regulatory agency (mhra) of united kingdom has posted a medical device safety alert concerning inspiration ls, and i series ventilator systems manufactured by event medical. all inspiration ventilators i series and ls 12.1" lcd built before 21 january 2015 are affected. according to the manufacturer, a component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. this failure could result in death or serious injury to a patient. the manufacturer advises users to discontinue use of the affected ventilators immediately until correction is completed. the manufacturer also advises affected users to take the following actions:- for users who have the ls, 5i, or 7i inspiration ventilator system models subject to this field safety notice, the manufacturer has identified a correction to this issue which requires removal of the potentially faulty component from the power board. for users who have older models that are not the ls, 5i, or 7i model, these ventilators should be taken out of service. these models are no longer supported with spare parts or software versions and should be retired. for details, please refer to the mhra website:https://mhra.Filecamp.Com/public/file/2bog-sl9dth3p if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 october 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Medical Device Safety Alert: eVent Medical Inspiration LS, and i Series Ventilator Systems
  • Manufacturer

Manufacturer