Dynamis and Gerialit Beds with DEWERT electrical system 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
    2013-01-29
  • 사례 출판 날짜
    2013-01-29
  • 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: hill-rom dynamis and gerialit beds with dewert electrical system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning dynamis and gerialit beds manufactured between october 1995 and june 2001 with dewert electrical system, manufactured by hill-rom. the affected model numbers are li146b1—li146bi, li146d1—li146di, li147b1—li147d1, li150a0—li150b0, li163b1—li163c1, prs0128, prs0199, prs0201, prs2001. the manufacturer wants to make aware of a potential safety issue regarding dynamis and gerialit beds manufactured and shipped from october 1995 to june 2001 that have dewert control boxes. it is possible for there to be unintentional movement of the bed when it is plugged in, including sudden collapse to the lowest position. in an effort to mitigate the potential for injury, the manufacturer requested customers that the labels should be applied to both sides of the bed as a reminder where a hand should not be placed, and to not climb under the bed. the manufacturer also advised customers to make sure that staff, patients, caregivers, and visitors do not work or crawl under any bed or other areas where unintended quick return to lowest position or collapse of the bed could cause entrapment that serious injury of death could occur. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226926 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 january 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Hill-Rom Dynamis and Gerialit Beds with DEWERT electrical system
  • Manufacturer

Manufacturer