Events

Alerte De Sécurité sur Extracorporeal Lithotripsy Equipment MODULARIS Variostar - Modular Variostar Record nº 10234230180. Lots: 4021; 5016; 5030; 5094; 5101; 5107; 5126; 5147; 5188; 5191; 6016; 6035; 6038; 6055.

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 Siemens Ltda..

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
    1703
  • Date
    2015-10-23
  • 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
    The company informs that if the MODULARIS system display hangs, there is a possibility that this will result in insufficient information for the treatment.
  • Cause
    Siemens healthcare has identified that on rare occasions, the modularis manual control display locks up and the information displayed on it is not updated. neither the amount of shock waves applied nor other parameters that have been changed by the user in the manual control will be displayed. this may result in insufficient information for treatment.
  • Action
    The company advises that whenever changes in parameters are made in the manual control of the MODULARIS, the user must make sure that the display is showing the new updated values. If the MODULARIS manual control display locks, stop the treatment immediately. Currently, the potential malfunction of the incorrect treatment data display can only be mitigated by the user when the user checks that the manual control display is showing the new values ​​updated after the parameters have been changed. Further information: Appendix II: Customer Letter Disconnect the MODULARIS manual control from the MODULARIS Variostar basic unit and reconnect it. The manual control will start automatically and display the correct values. Then treatment can continue.

Device

Extracorporeal Lithotripsy Equipment MODULARIS Variostar - Modular Variostar Record nº 1023423018...

Manufacturer

Siemens Ltda.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA