Events

OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80071260314. Serial number: see attached chart. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTD. 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
    1759
  • 날짜
    2015-11-23
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The problem may occur before or during an interventional fluoroscopy procedure. The total and unrecoverable loss of the monitor's display is a risky situation that prevents the use of the equipment for any need and therefore will require another equipment or that the patient is transferred. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and replacement parts.
  • 원인
    Security issue related to video loss of monitors during interventional procedures. a video switch power failure can result in loss of real-time video and reference monitors located in the procedural and control room areas. no radiology images will be displayed during a real-time acquisition or during review when the power supply fails.
  • 조치
    According to company information, the user can continue to use the system. Prior to each use, established procedures should be in place to treat patient in case of loss of fluoroscopy imaging during an examination. The user must ensure that the equipment operates before use. If the failure occurs during the interventional examination, it is advised to interrupt the acquisition of the image immediately and finish the examination to avoid unnecessary exposure. The company will contact you to replace the power supply of the video switch. Action code: FMI12237.

Device

OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80...

Manufacturer

GE Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTD.