Events

Safety Alert for AUTOPULSE RESTORATION SYSTEM MODEL 100. Anvisa Registry n ° 10429990044.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Indumed Comércio Importação Exportação de Produtos Médicos Ltda.; Zoll Circulation.

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
    1324
  • Date
    2013-11-08
  • 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
    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.
  • Reason
    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