Swift Mobil Shower Chair 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Etac Supply Center AB 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
    2012-11-22
  • 사례 출판 날짜
    2012-11-22
  • 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: etac swift mobil shower chair it has come to our attention that medical device manufacturer, etac supply center ab has issued afield safety notice regarding all swift mobil shower chairs with serial number 3829 to 11028. the manufacturer has received information from a few users of malfunctions with the swift mobile shower chair. it was reported that the casters in some cases are loose and in a few cases has fallen off. the manufacturer is unaware that loose casters would have resulted in any harm or serious injuries. there is however a potential risk for harm and injury if the shower chair loses a caster and thus instantly becomes unstable. the manufacturer has after thorough investigation concluded that several root causes has contributed to the reported loosening of casters. the required torque for the caster fastening screws to the frame has in some cases not met the factory specifications. therefore, the manufacturer will replace the casters of the affected shower chairs to ensure a continuous long term safe use. also, the manufacturer advised that there are no reasons for an immediate stop of using the affected product, however as an intermediate precautionary action awaiting the caster replacement, user facilities are requested to be observant and inspect the casters to see if there are visible signs of a caster coming loose. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 november 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Etac Swift Mobil Shower Chair
  • Manufacturer

Manufacturer