Events

Alerta De Seguridad O Notificaciones De Seguridad para HeartStart XL defibrillator/monitor

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
  • ID del evento
    MDA/2012/077
  • Número del evento
    CON203886
  • Fecha
    2012-11-08
  • Fecha de publicación del evento
    2012-11-08
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON203886?tabName=allTabs
  • 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
    Risk of immediate and unexpected loss of critical monitoring, defibrillation or non-invasive pacing. if a heartstart xl defibrillator/monitor is not connected to the mains and is used with a battery from the affected batch, it may shut down unexpectedly without providing the user with a low battery warning or audible alarm. the manufacturer published a field safety notice in september 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Acción
    Identify HeartStart XL defibrillator/monitors with affected batteries and affected spare batteries. If you have affected batteries, follow the guidance given in the Field Safety Notice. In particular: do not use device on battery power alone, and ensure you have access to an appropriate alternative device. Contact the manufacturer to arrange for a replacement battery.

Device

HeartStart XL defibrillator/monitor
  • Modelo / Serial
  • Descripción del producto
    Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made in Taiwan’ with ‘Date of Manufacture’ code ‘R-2011-12’.
  • Manufacturer
    Philips

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    MHRA