Carestation 620, Carestation 650, and Carestation 650c Anaesthesia Systems 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
    2017-10-13
  • 사례 출판 날짜
    2017-10-13
  • 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 carestation 620, carestation 650, and carestation 650c anaesthesia systems the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning carestation 620, carestation 650, and carestation 650c anaesthesia systems, manufactured by ge healthcare. the manufacturer has recently become aware that an incomplete seal can exist between the co2 absorber and the breathing circuit co2 bypass port assembly of the carestation 600 series systems. an incomplete seal can allow rebreathing of patient gases that have bypassed the co2 absorbent material and could result in unintended elevated levels of inspired co2 (fico2), which could lead to hypercarbia. to date, there have been no injuries reported as a result of this issue. the manufacturer is advising users as an interim solution to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathes if elevated fico2 levels are observed. if the fico2 levels cannot be adequately reduced with this action, users should consider switching to another anaesthesia delivery device. the manufacturer is releasing revised parts that minimise the likelihood of incomplete gas flow through the co2 absorbent canister. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-01300-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 october 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: GE Healthcare Carestation 620, Carestation 650, and Carestation 650c Anaesthesia Systems
  • Manufacturer

Manufacturer