Events

Alerta De Seguridad O Notificaciones De Seguridad para HeartStart XL defibrillator/monitor with M3516A batteries

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/2013/066
  • Número del evento
    CON305480
  • Fecha
    2013-08-15
  • Fecha de publicación del evento
    2013-08-15
  • 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/CON305480?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
    Seriousdefibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from 6 months to 3 months. this applies to new batteries with the lot number prefix ‘lk’. philips is supplying an addendum with battery orders and heartstart xl monitor/defibrillator orders stating these changes (march 2013) to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6).
  • Acción
    Ensure all relevant staff are aware of the changes. Ensure that the addendum (see appendix) is attached to the instructions for use and service manuals accordingly. Be aware that this addendum supersedes any previous guidance given by Philips regarding battery life and capacity test frequency.

Device

HeartStart XL defibrillator/monitor with M3516A batteries
  • Modelo / Serial
  • Descripción del producto
    HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Distributed by Philips and Cardiac Services UK & Ireland. NB: Philips HeartStart XL batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use).  These batteries are still supported with relevant instructions for use and labelling.
  • Manufacturer
    Philips

Manufacturer

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