X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 31001/50215/95920/95921/95933/320113. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), 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
  • 사례 ID
    1544
  • 날짜
    2015-03-23
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    According to the registry holder, there is a serious accident for the patient and operator / technician resulting from the problem: "For the patient: • There is a possibility of disconnection or movement of invasive medical devices. For the Operator / Technician: • There is a possibility of there are compression / crush points in the substructure; and • A possibility of retention between the table and the gantry if the Operator / Technician positions between them to move the patient forward.
  • 원인
    Considering that the maintenance latch is secured and the stem of the maintenance latch is broken, the tabletop can float freely, causing an involuntary horizontal movement.
  • 조치
    The company directs the operator to notice a horizontal free floating movement of the table during normal clinical use, immediately stop using the system and contact your Maintenance Engineer. It is important to keep the Safety Warning with the Instructions for Use (IFUs) of the equipment.

Manufacturer