Events

Alerta De Seguridad O Notificaciones De Seguridad para FRED easy Defibrillators manufactured by Schiller

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 Schiller.

¿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/2012/042
  • Número del evento
    CON172285
  • Fecha
    2012-07-11
  • Fecha de publicación del evento
    2012-07-11
  • 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/CON172285?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
    A false defibrillator error message, "transistor error", displays on screen and requires the device to be re-started. this problem may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient. restarting of the defibrillator after display of a false error message may result in a delay to defibrillation. a software solution is either already available or under development, depending on the age of device. the older 1g units with serial numbers of 8 and 9 digits (manufactured from 2003 to 2006 inclusive) currently cannot be upgraded, as the software is under development. amazon medical will contact affected customers to provide further information, at a later date. for the remaining devices, the software will be deployed via a sd card for installation by users or the manufacturer.
  • Acción
    Identify affected defibrillators; see manufacturer’s Field Safety Notice. MDA/2012/042 and MDA/2012/043 refer to this Field Safety Notice. If affected, contact Amazon Medical Ltd immediately for software upgrade deployment details. Provide Amazon Medical Ltd with up to date contact details via return of the fax back confirmation form in the FSN. Until software update is deployed, be aware of this problem which, if it occurs, can be rectified by a restart.

Device

FRED easy Defibrillators manufactured by Schiller
  • Modelo / Serial
  • Descripción del producto
    FRED easy Defibrillators manufactured by Schiller. All devices are affected. Devices are distributed by Amazon Medical Ltd. Affected defibrillators: NOTE: FRED easyport is not affected Product All models Article number FRED easy Basic REF BR-FREDEASY FRED easy ECG on-screen REF BR-FREDEE FRED easy Manual REF BR-FREDEEM
  • Manufacturer
    Schiller

Manufacturer

Schiller