Events

Affinity® Four Birthing Bed 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Hill-Rom 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
    2012-05-07
  • 사례 출판 날짜
    2012-05-07
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120507.html
  • 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: hill-rom affinity® four birthing bed medical device manufacturer, hill-rom, has issued a field safety notice concerning affinity® four birthing bed. hill-rom found that some of the affinity® four birthing beds, with serial number h331aa4785 through n081aa7966 produced prior to march 21, 2012, may experience problems with the brakes. the problem may result in unwanted bed movement. the manufacturer has developed an enhanced braking system for these beds and will modify the affected beds. the manufacturer also advised users to test the brake of the beds to make sure that it operates as normal until installation of the new braking system. according to the local supplier, solar-med limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 07 may 2012.

Device

Affinity® Four Birthing Bed
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Hill-Rom Affinity® Four Birthing Bed
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom