Events

MYLA SERVER HP PROLIANT - DL 380-G8 AND DI350- G6 linked to VITEK MS (registration 10158120668). The middleware is an item not registered in Anvisa.//// All the Myla middleware installed in the national territory are inserted in this field action. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomérieux Brasil SA.; bioMérieux S.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
    1574
  • 날짜
    2015-05-04
  • 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
    According to the registry holder, the device is installed on the Vitek MS system, whose registry is 10158120668 but can also be employed as a data management middleware extracted from various devices. The problem may occur many times over the life cycle of the product. The overall risk associated with the problem is greater in version 3.X.
  • 원인
    The myla server may stop working on clients with a large volume of routine, due to the amount of data to be managed. the server stops because of a security mechanism that prevents its functionality in cases where execution takes more than 5 minutes to process.
  • 조치
    For correction the company will create a software set-up to modify the initialization phase of the MYLA to be installed by an employee of the registration holder in Brazil. The fix will maintain server performance. The company will write a letter to the owners of the Vitek MS equipment, in which the MYLA middleware is installed, stating the problem and installing the correct one.

Device

MYLA SERVER HP PROLIANT - DL 380-G8 AND DI350- G6 linked to VITEK MS (registration 10158120668). ...

Manufacturer

Biomérieux Brasil SA.; bioMérieux S.A.