Alenti Lift and Hygiene Chair 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 ArjoHuntleigh 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
    2013-05-08
  • 사례 출판 날짜
    2013-05-08
  • 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: arjohuntleigh alenti lift and hygiene chair health canada has issued a medical device safety alert, concerning alenti lift and hygiene chair., manufactured by arjohuntleigh. arjohuntleigh, in collaboration with health canada, issued the safety notice to re-iterate safety information to prevent the risk of chair tipping and patient falls with the alenti lift and hygiene chair. these incidents can be caused by operator use error and patient factors, and can lead to serious patient injury or death. between 2004 and 2007, arjohuntleigh conducted field safety correction actions to provide improved safety instructions and warnings to reduce the risk of alenti chair tipping and patient falls. the incident rate has since declined; however, arjohuntleigh continues to receive several incident reports in canada each year. to further reduce the number of incidents associated with the alenti chair, arjohuntleigh would like to re-iterate the following important safety information. alenti chair tipping and patient falls can occur if an operator fails to strictly follow all operating and safety instructions in the instructions for use. alenti chair tipping and patient falls have continued to occur in canada, some of them leading to serious patient injuries and death. all personnel who may be involved in operating the alenti chair should be familiar with the risk factors that are known to cause chair tipping and patient falling incidents. for details, please visit the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/ 29019a-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: ArjoHuntleigh Alenti Lift and Hygiene Chair
  • Manufacturer

Manufacturer