National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는
Colombia
에서 Datascope Corp 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.
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 states that it has identified that the referenced devices have been packaged with instructions for incorrect use and belonging to another device, which can lead to confusion for users and potentially serious adverse events on the patient.
SENSATION PLUS 8FR and SENSATION PLUS 7.5FR, lots 3000001484 up to 3000024495.
제품 설명
They are used for aortic counterpulsation therapy, by means of inflation of the balloon during diastole and deflation during systole, it increases the blood supply to the heart muscle and decreases the work of the left ventricle.