Events

Alerte De Sécurité sur AUTOPULSE RESTORATION SYSTEM MODEL 100. Anvisa Registry n ° 10429990044.

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 Indumed Comércio Importação Exportação de Produtos Médicos Ltda.; Zoll Circulation.

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
    1324
  • Date
    2013-11-08
  • 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
    Complaints received by the product manufacturer associated with an "unexpected shutdown of Autopulse compressions" are commonly caused by users failing to properly perform the required preventive maintenance and daily check-in tasks. Proper use of the product requires daily rotation routine and monthly battery cycle tests (daily battery charging and rotation in combination with monthly battery cycling test). The manufacturer, in order to minimize the risk of such situations, established the need for daily verification by the user of the product of the operation of the batteries of these devices. This is not only a recommendation, since the user must perform the procedures in order to avoid risk of malfunction or non-operation of the equipment. Anvisa's Technovigilance Unit is monitoring the case and new information, as soon as it is available, will be updated in this alert.
  • Cause
    Need for daily battery management.
  • Action
    The manufacturer of the product has established a procedure for daily verification of the status of the equipment batteries, which will be applied to Brazil by

Device

AUTOPULSE RESTORATION SYSTEM MODEL 100. Anvisa Registry n ° 10429990044.

Manufacturer

Indumed Comércio Importação Exportação de Produtos Médicos Ltda.; Zoll Circulation
  • Source
    ANVSANVISA