Events

EV1000NI clinical platform 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Edwards Lifesciences Llc || Edwards Lifesciences Ag 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
    R1712-575
  • 사례 연번
    2016EBC-0014585
  • 날짜
    2017-12-29
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=60
  • 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
  • 원인
    The manufacturer informs that it has detected that the devices are susceptible to appear an error message "hrs out of range", when they are six months after the date of manufacture, because said situation could lead to possible delays in the procedures and events. adverse on patients.

Device

EV1000NI clinical platform
  • 모델명 / 제조번호(시리얼번호)
    HRS sensors, reference EVHRS
  • 제품 설명
    The NI (non-invasive) clinical platform EV1000NI and its accessories are a monitoring system that shows hemodynamic parameters derived from continuous noninvasive measurements of blood pressure waves. The EV1000NI system helps physicians in the assessment of the patient's physiological status and supports the clinical decision related to hemodynamic optimization. The EV1000NI clinical platform is indicated for use in patients over 18 years of age in whom the balance between cardiac function, fluid status and vascular resistance requires continuous evaluation. Additionally EV1000NI is indicated for use in patients with co-morbidities for which hemodynamic optimization and invasive measures are difficult. EV1000NI measures non-invasive blood pressure and the associated hemodynamic parameters.
  • Manufacturer
    Edwards Lifesciences Llc || Edwards Lifesciences Ag

Manufacturer

Edwards Lifesciences Llc || Edwards Lifesciences Ag