Events

Patient Browser and Content Manager. Anvisa Registry n ° 80042070025. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Brainlab Ltda; Brainlab 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
    1732
  • 날짜
    2015-11-16
  • 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
    If a reference data sequence is deselected and the error persists, the magnitude of the offset or distortion will vary depending on the differences between the two data sequences. In some cases the displacement or distortion will be clearly visible when the plan is used in a Brainlab planning or navigation system. However, an offset may also not be so obvious. If a displacement or distortion occurs and is not detected during data review, diverting the information displayed in Brainlab's planning or navigation software may have a negative impact on a patient's clinical decisions. No negative effect on patients related to this problem has been reported to Brainlab by any customer to date.
  • 원인
    By actively deselecting a merged reference data stream in content manager (the default setting is "selected"), a point, an object, or a path may appear to be offset and / or distorted in the brainlab navigation or planning software that is used subsequently.
  • 조치
    Field correction (software update). Recommendations for product users: Do not deselect individual data streams where a Point, an Object, or a Trajectory is planned. If you are unsure about the data sequence in which the Point, Object, or Trajectory was planned, do not deselect any of the contents of the plan. Instead, open the whole plane. Before beginning treatment of the patient, always check the plausibility of all the information inputs and outputs of the device. Company code for the field action: CAPA-20150804-001474. Access and read the warning message published by the manufacturer, available at: http://portal.anvisa.gov.br/wps/wcm/connect/df7295804a9dfab290a4b7218f91a449/Seguran%C3%A7a+em+Campo_1732.pdf ? MOD = AJPERES

Device

Patient Browser and Content Manager. Anvisa Registry n ° 80042070025.

Manufacturer

Brainlab Ltda; Brainlab AG