Liko Standard SlingBar 450 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Liko 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
    2013-05-20
  • 사례 출판 날짜
    2013-05-20
  • 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: liko standard slingbar 450 it has come to our attention that medical device manufacturer, liko, has initiated a field safety corrective action concerning standard slingbar 450. the affected product numbers are 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 or 5019013 (distributed between jan 1980 and nov 2012). the affected product numbers may be bundled with the golvo 1000, 3000, and 7000 series lifts, viking m, viking l, likolight 100 & 125, caroli 101, and uno 100, 101 & 102. the manufacturer has become aware of a safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver or bystander could result from tripping or otherwise falling into the sling bar, typically when the lift is parked or stored when not in use. the sling hook on the end of the sling bar could pierce a body structure such as the head, shoulder or groin. the manufacturer advises users to continue to follow safe lifting practices, and not to allow unauthorized persons, especially children, to play around or operate the lift. the current standard slingbar 450 model is designed in such a way that impalement may occur. liko has designed a safety cover to put on the top of the sling bar in order to reduce the risk of impalement. the manufacturer will provide affected customers modification kits. the customers will implement the correction themselves. where needed, a hill-rom technician or third party will complete the correction. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Liko Standard SlingBar 450
  • Manufacturer

Manufacturer