Events

Safety Alert for External Automated Defibrillator

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
    553
  • Date
    2002-03-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    An ecri member hospital reported that its defibrillators will discharge excessive pediatric patient energy when operated in the automatic mode of the external defibrillator (aed), sometimes referred to as advisory mode. in this mode, the defibrillators selected the first level of shock energy used for adults. depending on the model, this energy level will range from 120 to 200 joule. an injury can occur if the child takes sock with these energies.
  • Action
    (Note: Refer to the original report quoted below to use logical reasoning following recommendations.) ECRI recommends the following: (1) Alert all users of Automatic External Defibrillator (AED) or manual defibrillators and cardioverters with automatic operation for this report. (2) Determine in your hospital that any existing AEDs are approved for use in pediatrics. Tell the clinical staff that there are no other automatic external defibrillator devices available for use in pediatric patients. (3) Do not store pediatric defibrillation pads along with standard defibrillation devices that are not approved for pediatric use. For manual defibrillators incorporating AED capability, pediatric defibrillation electrodes can be stored together with the unit, but trainings should emphasize that the unit can be used in the external defibrillator mode in AED mode to defibrillate the infant patient. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

External Automated Defibrillator
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA