Events

Alerta De Seguridad O Notificaciones De Seguridad para CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP

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 Maquet.

¿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
    2017-03-07
  • Fecha de publicación del evento
    2017-03-07
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/cardiosave-hybrid-intra-aortic-balloon-pump-iabp-and-cardiosave-rescue-iabp-damaged-lithium-ion-batteries-may-give-off-smoke-a-bad-smell-or-produce-sparks
  • 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
  • Causa
    Manufactured by maquet – until storage cases are available, avoid carrying spare batteries when transporting the iabp to reduce the risk of dropping and damaging them.
  • Acción
    Identify affected batteries: they have part number 0146-00-0097 and were distributed from 12 December 2011 to 9 November 2016.Maquet’s Field Safety Notice (FSN) advises users not to take spare batteries when transporting the IABP until they receive a re-usable transport and storage case.Until the cases are available use an inverter and a transport AC power supply instead of carrying spare batteries.If these power supplies are not available, carry out an individual risk assessment for the continued use of the devices with batteries whilst in transport.Contact Maquet to acknowledge receipt of the FSNArrange for Maquet to provide (free of charge) warning labels to be applied to batteries and re-usable battery transport and storage cases.

Device

CARDIOSAVE Hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE Rescue IABP
  • Modelo / Serial
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Dirección del fabricante
    Hari Rajendran, Regulatory Affairs Officer, Maquet Ltd Tel: 0191 519 6200Email hariraj.rajendran@getinge.com
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    MHRA