Events

External Automated Defibrillator 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 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
    553
  • 날짜
    2002-03-08
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    An ecri member hospital reported that its defibrillators will discharge excessive pediatric patient energy when operated in the automatic mode of the external defibrillator (aed), sometimes referred to as advisory mode. in this mode, the defibrillators selected the first level of shock energy used for adults. depending on the model, this energy level will range from 120 to 200 joule. an injury can occur if the child takes sock with these energies.
  • 조치
    (Note: Refer to the original report quoted below to use logical reasoning following recommendations.) ECRI recommends the following: (1) Alert all users of Automatic External Defibrillator (AED) or manual defibrillators and cardioverters with automatic operation for this report. (2) Determine in your hospital that any existing AEDs are approved for use in pediatrics. Tell the clinical staff that there are no other automatic external defibrillator devices available for use in pediatric patients. (3) Do not store pediatric defibrillation pads along with standard defibrillation devices that are not approved for pediatric use. For manual defibrillators incorporating AED capability, pediatric defibrillation electrodes can be stored together with the unit, but trainings should emphasize that the unit can be used in the external defibrillator mode in AED mode to defibrillate the infant patient. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

External Automated Defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA