Events

Alerte De Sécurité sur External Automated Defibrillator

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 N/A.

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
    553
  • Date
    2002-03-08
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA