Events

Draeger mechanical fan AVOID V300, AVOID V500 and BABYLOG VN500 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh 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
    I1507-329
  • 사례 연번
    2013EBC-0010354
  • 날짜
    2015-07-30
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=175
  • 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 states that it has detected the reduced capacity of the batteries belonging to the optional ps500 external battery, the device will activate the "low battery" sequential alarms, and it will not be possible to predict the remaining operating time until the fan stops, this behavior obeys only to the failure of the batteries and not to a damage in the main unit of ventilation, leading to the occurrence of potentially adverse events for the patient for not having backup supply, in case of absence of main power supply.

Device

Draeger mechanical fan AVOID V300, AVOID V500 and BABYLOG VN500
  • 모델명 / 제조번호(시리얼번호)
    equipment that has the optional PS500 external battery module installed.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 제품 설명
    The mechanical ventilator avoids V300 is used intra - hospitally to administer invasive and non - invasive ventilatory support to adult, pediatric and neonatal patients through the generation of positive pressure endiversas ventilatory modalities: mandatory, assisted andpontaneous. Simultaneously, the team monitors the mechanics and respiratory function of the patient. Its main clinical indication is to temporarily support respiratory function in those patients who are unable to carry out an effective spontaneous respiration.
  • Manufacturer
    Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh

Manufacturer

Drägerwerk Ag & Co. Kgaa || Drager Medical Gmbh