Devices of artificial ventilation of the lungs with accessories: Devices of artificial ventilation of the lungs Evita Infinity V500, Babylog VN500 를 위한 리콜 또는 안전성 경고

Ministry of Health of the Republic of Belarus에 따르면, 해당 리콜 또는 안전성 경고 는 Belarus 에서 Drager Medical GmbH, GERMANY 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
    Recall / Safety alert
  • 사례 연번
    ИМ-7.97782
  • 날짜
    2014-04-03
  • 사례 국가
  • 사례 출처
    MHRB
  • 사례 출처 URL
  • 비고 / 경고
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • 데이터 추가 비고
  • 원인
    As part of the supervisory activities of drager medical gmbh, it became known that when using an additional ps500 power supply unit when connected to evita infinity v500 and babylog vn500 ventilators, the battery capacity holds the charge not as long as expected, although the battery indicator shows a fairly charged battery. in this case, the indicators (alarms) "low battery" (battery low) and "power source discharged" (battery depleted) do not always work when the battery level is below 10%. to ensure the normal operation of the devices, it is necessary to contact the representative of drager and organize the exchange of the battery as a temporary solution. before exchanging the battery, drager recommends: 1. use an additional power supply to transport the patient only if absolutely necessary. 2. do not rely on the battery status indicator. 3. always monitor the patient and the ventilator during transport. ensure that there is a breathing bag for manual ventilation, as indicated in the manual for ventilators. 4. if the power supply is discharged during transportation, it is necessary to provide manual ventilation of the lungs and immediately connect the ventilator to the wall-mounted power supply to resume ventilation of the lungs.

Manufacturer