Events

CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical Navigation System. Registration nº 80145901453. SERIAL NUMBER: NAVIGATION SYSTEM EP - CARTO 3 System: SNs: 50573; 51027; 51021; 50572; 11879; 51022; 50203; 51018; 51020; 50128; 11179; 50530; 50532; 5977 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER 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
    1725
  • 날짜
    2015-11-03
  • 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 company informs that there will be risk if the ultrasound image is being used to monitor the patient during the electrophysiology procedure. If there is a power outage during the ride, the ultrasound image will not reappear until the CARTO® 3 System is restored.
  • 원인
    The company holding the registry informs that the intracardiac ultrasound image will disappear if the power of the carto® 3 navigation system is interrupted and this may present a safety problem if the electrophysiologist is using ultrasound imaging to monitor the patient during the electrophysiology. the ultrasound image will not reappear until the carto® 3 system is restored.
  • 조치
    • Read this Field Safety Notice carefully (Appendix). • Give this notice to the people at your facility who need to be informed about the problem, including relevant clinical professionals who are involved in the use of SOUNDSTAR® eco Catheters. • Keep a copy of this letter with the product. • Be aware of this Field Safety Notification

Device

CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC