Monitor Arm AC 3000 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Draeger Medical GmbH 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
    2013-11-29
  • 사례 출판 날짜
    2013-11-29
  • 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: draeger monitor arm ac 3000 medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning its adjustable monitor arm [model no.: ac3000; part no.: g92756 and g94499]. according to the manufacturer, the other part numbers are not affected. the manufacturer has discovered a case in which the monitor support bracket detached from the joint pin at the bottom of the height adjustable spring arm ac3000. the monitor support bracket fell down together with the monitor until it was only held by electrical cable connections. although no one was injured, a falling monitor support has the potential to cause personal injury. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. the manufacturer advises affected users to handle the monitor arm with care and to pay attention to any increasing free play between the pins and the monitor arm. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 november 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Draeger Monitor Arm AC 3000
  • Manufacturer

Manufacturer