Events

Notificaciones De Seguridad De Campo acerca de Zoll AED Plus Defibrillator

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Zoll Medical Corporation.

¿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
    Field Safety Notice
  • Fecha
    2009-12-10
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zoll-aed-plus-defibrillator-10.12.2009&id=2a8cf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    The zoll aed plus defibrillator may not deliver therapy.
  • Acción
    1. Ensure that the relevant personnel in your organisation are made aware of this issue.  2. Determine if you have purchased the affected serial numbers of this product, AED Plus devices with serial numbers below X_ _ _200000.  3. If you have an affected device confirm that the recommended actions have been completed:  Ensure that the date when the batteries were installed in your device has been checked.  a. If batteries were installed more than three (3) years ago, replace the batteries as soon as possible and add the label provided by Zoll showing the next scheduled replacement date. Read and add the addendum incorporating this information to the administrator’s guide that was provided by Zoll.  b. If batteries are not more than three (3) years old, add the label provided by Zoll completed with the next scheduled replacement date. Read and add the addendum, provided by Zoll, incorporating this information to the administrator’s guide.

Device

Zoll AED Plus Defibrillator

Manufacturer

Zoll Medical Corporation