GlideScope GVL Video Laryngoscope Reusable Blades 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Verathon Inc 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
    2012-12-03
  • 사례 출판 날짜
    2012-12-03
  • 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: verathon glidescope gvl video laryngoscope reusable blades the united states food and drug administration (fda) posted a firm press release concerning glidescope gvl video laryngoscope reusable blades, manufactured by verathon inc. the manufacturer initiated a voluntary recall of glidescope gvl video laryngoscopes reusable blades that were manufactured between december 2010 and august 2011. the recall includes the following models within the specified serial number ranges: glidescope gvl 3, 0574-0007: md10500 to md112387; glidescope gvl 4, 0574-0001: lg105000 to lg112758 and glidescope gvl 5, 0574-0030: xl105000 to xl111798. the firm voluntarily recalled the products after learning about design characteristics leading to cracked and broken blades. these laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient’s mouths and obstructing the airway or being swallowed. the manufacturer suggests healthcare facilities that have glidescope gvl recalling reusable blades to stop using the blades and contact verathon customer care to obtain a replacement blade. for details, please refer to the following fda website: http://www.Fda.Gov/safety/recalls/ucm330305.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 3 december 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Medical Device Safety Alert: Verathon GlideScope GVL Video Laryngoscope Reusable Blades
  • Manufacturer

Manufacturer