Events

Alerta De Seguridad para HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

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 Ltda..

¿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
    1022
  • Fecha
    2010-06-02
  • 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
    According to information presented by Philips Medical Systems Ltd., after two years of continuous use mechanical wear caused by vibration and frequent disconnections may cause an intermittent electrical connection between the battery and the equipment. The power outage during the use of the equipment may cause it to restart with interruption of therapy (monitoring of the electrocardiogram / electric shock for defibrillation of the heart muscle). #### Update (20/06/2012): Philips Medical Systems Ltda informed the UTVIG about the completion of the field action. According to the company, the addendums to the instructions for use were sent to affected customers in Brazil.
  • Causa
    Blinking electrical connection between the battery and the equipment, which may cause the defibrillator to fail.
  • Acción
    The company sent an informative letter to customers, with an addendum to the instructions for use of the equipment (Notice of Application of the Instructions for Use of the Lithium Ion Battery M3538A). It is recommended that all affected batteries be replaced after two years of continuous service, or when the battery capacity calibration fails, whichever comes first. The details of the instructions should be verified in the Letter to Customers (available at http://portal.anvisa.gov.br/wps/wcm/connect/f13aa60042b4e27f8b89cbb134f70e0f/Carta+a++Clients.pdf?MOD=AJPERES) and in the Addendum to Instruction Manual (available at http://portal.anvisa.gov.br/wps/wcm/connect/3b74638042b4e3228b92cbb134f70e0f/Adding+to+Manual+of+Instructions+.pdf?MOD=AJPERES) .

Device

HEARTSTART MRX DEFIBRILLATOR - Models M3535A and M3536A. Anvisa Registry: 10216710136.

Manufacturer

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