Events

Safety Alert for DEFIBRILLATOR DF-03. Registro Anvisa: 80332620005. Products affected: See list at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/953_produtos_afetados.pdf

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Transform Tecnologia de Ponta Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    953
  • Date
    2009-02-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The reason for product repair is related to one of the batches of the relay (electronic component) involved in the release mechanism of the equipment's electrical discharge (defibrillation). Such components may undergo premature degradation, cease to function before the programmed time and thus render the defibrillator inoperable. The manufacturer informed that it has already sent a technical newsletter to its sales representatives, informing the procedures for forwarding the products to be corrected. The Technovigilance Unit is following up on this case.
  • Reason
    One of the parts (relay) of the equipment may degrade prematurely, compromising the operation of the product.
  • Action
    Recommended actions for product users are as follows: (1) Check if there is any equipment affected by this alert in your Health Facility; (2) If any, segregate the affected equipment (s), replacing it with equipment (s) in good conditions of use, if possible; (3) Identify the equipment (s) segregated with a poster or banner so that they are not inadvertently used; (4) Please contact the manufacturer / recorder of the product registration (Transform Tecnologia de Ponta Ltda.), Informing that you have equipment under risk in your Health Care Center. The identified products must be sent to the Technical Assitance of the factory , which will perform the exchange of components that present a risk of failure.

Device

DEFIBRILLATOR DF-03. Registro Anvisa: 80332620005. Products affected: See list at http://www.anvi...

Manufacturer

Transform Tecnologia de Ponta Ltda.