D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 GE Healthcare 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
    2015-04-30
  • 사례 출판 날짜
    2015-04-30
  • 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: ge healthcare d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors australian therapeutic goods administration (tga), has issued a medical device safety alert concerning d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors, manufactured by ge healthcare. the affected devices are identified as follow:- d-fend: product number: 876446-hel; lot numbers: j9964985, j10201698, j10258248, j10284871, j10284872, j10344108 d-fend+ : product number: 881319-hel ; lot numbers:: j9906966, j9965152, j10258251, j10300071 the manufacturer has recently become aware of a potential safety issue due to loss of gas monitoring associated with occlusion of specific d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors. occlusion of specific lots of d-fend/d-fend+ water traps could occur immediately after replacement. this water trap occlusion could cause a loss of respiratory airway gas monitoring. when this issue is detected the connected monitoring device will issue an audio alarm and display “low gas sample flow”, “replace water trap” or “sampling line blocked” warning messages. unattended or prolonged warnings could lead to an adverse clinical situation if the co2 value would rapidly change in certain clinical conditions affected users are advised to collect and dispose of the affected water traps. the manufacturer will replace all affected products. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00366-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 april 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: GE Healthcare D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors
  • Manufacturer

Manufacturer