Events

Alerta De Seguridad para DEFIBRILLATOR HEARTSTART XL M4735A - Registration 10216710063 - Serial numbers: as per the annex. http://en.wikipedia.org/w/index.php/

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1179
  • Fecha
    2012-09-13
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    The device may shut down unexpectedly without providing the user with a warning message or low battery tone. The XL is capable of running on AC power without a battery. Anvisa is following this field action.
  • Causa
    If the xl defibrillator / monitor (m4735a) is used in a patient when ac power is not in use with a battery code r-2011-12, it may fail.
  • Acción
    The record holder recommends: Operate the XL with AC power instead of battery power only. • If you need to operate the XL with battery power only, make sure the battery is of a different Manufacturing Date (it should not have code R-2011-12 for the Date of Manufacture). • If you can not operate with AC power only or find a battery with a date of manufacture other than the one identified above, use an alternative energy source for treatment or therapy (eg, defibrillator / standby monitor). The record holder shall establish action plan for the exchange of battery code R-2011-12.

Device

DEFIBRILLATOR HEARTSTART XL M4735A - Registration 10216710063 - Serial numbers: as per the annex....

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA