Animas Insulin Pump 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Animas Corporation 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
    2012-07-25
  • 사례 출판 날짜
    2012-07-25
  • 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: animas insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device safety alert concerning animas insulin pump manufactured by animas corporation. according to animas, some patients experienced gradual wear of their insulin pump keypad that led to damage, such as tearing or peeling of the edge of the keypad from the pump. therefore, animas has improved the durability of the insulin pump keypad, which includes the ok button, up arrow/ down arrow buttons, and the contrast button. the manufacturer advised all animas insulin pump users to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of pump inspection. animas provides a warranty for a period of four years from the date of purchase in most cases. if a customer has a confirmed issue related to the keypad and he/she is covered by the animas warranty, animas will replace the pump at no charge. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Animas Insulin Pump
  • Manufacturer

Manufacturer