Events

Safety Alert for ALL TWO-PHASE DEFIBRILLATORS (ALL MANUFACTURERS).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    705
  • Date
    2003-04-17
  • 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
    For more information and information, contact Tecnovigilância / ANVISA, and inform the reference number of this Alert. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/tecnovigilancia/index.htm for you to notify if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
  • Reason
    Defibrillators using biphasic waveforms generally require lower levels of energy to achieve defibrillation than those using single-phase waveforms. there is consequently the possibility of confusion.
  • Action
    All users of the defibrillators should be aware of the following statement made by MHRA and reputed professional organizations. See the Annex in English at: http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwSearchResults/2AAB3B621AC478A580256D10003BB26C?OPEN - And in Portuguese at: http://www.anvisa.gov.br/ tecnovigilancia / index.htm - Tell all departments of the need to be aware of this alert.

Device

ALL TWO-PHASE DEFIBRILLATORS (ALL MANUFACTURERS).
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA