Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Biomérieux Brasil SA.; bioMérieux S.A..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1574
  • Date
    2015-05-04
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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.