Alerta De Seguridad para Heartstart MRx Defibrillator, Philips brand, model: M3535A, M3536A, ANVISA Registration # 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.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 MRx may stop charging, defibrillating or stimulating, causing a delay in therapy. According to the manufacturer, you can continue to use the MRx before receiving the hardware upgrade, as long as you notice that if the MRx displays a red X on the RFU (ready-to-use) indicator during automated testing, a fault has been detected and can prevent the delivery of a shock or stimulation due to this problem. If this is found you should turn the Therapy button to Monitor. An INOP message describing the fault is displayed. If necessary, run an operational check for more information. If the condition persists, remove the device and call for service. Use a backup defibrillator in case an affected MRx does not deliver therapy.
  • Causa
    An internal component in the heartstart mrx therapy board may malfunction, potentially affecting the ability to deliver therapy. mrx, specifically, may be unable to carry and deliver the shock. in addition, when used for external stimulation, malfunction may result in loss of capture during stimulation. the mrx may display a red x on the rfu (ready for use) indicator during automated testing informing the user that a fault has been detected and that it can prevent the delivery of a shock and stimulation.
  • Acción
    Field correction and software update


  • Empresa matriz del fabricante (2017)
  • Source