Events

Alerta De Seguridad O Notificaciones De Seguridad para Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Philips.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-11-29
  • Fecha de publicación del evento
    2018-11-29
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/batteries-for-the-heartstart-mrx-monitor-defibrillator-may-fail-to-charge-or-to-provide-power
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
    This MDA is related to our previous alert, MDA/2018/002, advising users of a significant delay in the supply of batteries for the HeartStart MRx monitor/defibrillator.The supply of batteries for these devices has been halted again due to further manufacturing problems. There is likely to be an ongoing significant delay in the fulfilment of outstanding orders.
  • Causa
    Philips m3538a lithium-ion batteries manufactured from 28 december 2017 to 20 march 2018 inclusive for the heartstart mrx monitor/defibrillator may have an internal component failure.
  • Acción
    Identify affected batteries highlighted in the manufacturer’s Field Safety Notice and remove them from service. Ensure alternative devices are available as defined in local risk assessment procedures until you can source a new battery. Follow the manufacturer’s instructions for use on battery management to keep your existing batteries in the best possible condition. Ensure there are systems in place to replace affected batteries as a priority when supplies are resumed.

Device

Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.
  • Modelo / Serial
  • Manufacturer
    Philips

Manufacturer

Philips
  • Dirección del fabricante
    Clare Fripp Head of Q&R Philips UK& Tel: 07920 763 640Email: clare.fripp@philips.com
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    MHRA