cryocam system 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

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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 연번
    2013EBC-0009606
  • 날짜
    2017-10-11
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고

Device

  • 모델명 / 제조번호(시리얼번호)
    Deflectable Introducer Flexcath Advance
  • 제품 설명
    Description of the system CRYOCATH's CRYOCATH technology from MEDTRONIC combines the advantages of cardiac catheter ablation and cardiac ablation CRYOCATH from MEDTRONIC produces cryogenic (extremely cold) controlled conditions in the cooling segment of a long, flexible and bi-directional catheter. The system delivers cryogenic temperatures to the internal walls of a latent heart approaching the heart through the body vasculature from a puncture in the skin. The procedure is done to correct electrophysiological abnormalities that lead to irregular or erratic heartbeats. This selectively destroys (performs ablation) groups of cardiac cells (sites generating the arrhythmia), which causes or propagates the abnormality. System is composed of the console, catheters, electrical and gas connectors (called as umbilicals) and other accessories. The figure below shows the components connected to form the system. Crio universal console: the console houses the electronic components and the software to control and record the procedure, stores and controls the delivery of liquid refrigerant under high pressure through the umbilical cable coaxial to the catheter, recovers the expanded vapor from the catheter refrigerant under vacuum, and Disposes the refrigerant through the hospital waste management system. The hardware controls the safety monitoring system while the software supplies the patient information, user interface, procedure temperature, temperature / time set point in automatic mode and information from Procedure data. Electric umbilical cable: the sterile electric umbilical cable is a cable
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA