Events

Alerta De Seguridad O Notificaciones De Seguridad para Lucas external cardiac compressor

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 Jolife AB.

¿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/2007/013
  • Número del evento
    CON2030218
  • Fecha
    2007-02-06
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2030218
  • 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
    The mhra has received reports of: inadequate ventilation in non-intubated patients thoracic cage and lung damage raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply.
  • Acción
    Ensure that all users of this device are aware of the ventilation update to the instructions for use from Jolife AB, appended to this Alert. This now states that when used in non-intubated patients the device can be safely stopped to allow intermittent manual ventilation. Ensure the device is placed correctly, according to its instructions for use (IFU). If the device is powered by oxygen and used in confined spaces (e.g. ambulances) ensure there is adequate ventilation. In ambulances always run the ventilation at the highest capacity and do not recirculate the air. If the device is powered by oxygen always ensure there is an adequate oxygen supply for both the Lucas device and the patient’s respiratory requirements.

Device

Lucas external cardiac compressor
  • Modelo / Serial
  • Descripción del producto
    Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd. The Lucas external cardiac compressor is used for external cardiac chest compressions on adult patients who have acute circulatory arrest. The manufacturer defines this as the absence of spontaneous breathing, no pulse and the loss of consciousness. This device is only intended for temporary use where manual resuscitation would otherwise be used. The model of device presently used in the UK, with serial numbers up to and including 14063999, is powered by either oxygen or medical air from the wall outlets of hospitals and ambulances, or from cylinders. This model was manufactured up to May 2006 and uses IFU 100081-00 Rev B. Copies of the device’s instructions for use and its ventilation update, are available from the manufacturer’s website www.lucascpr.com/lucas.php?sid=9 (external link) Device users should ensure they use the appropriate instructions for their device, as there is a new model with serial numbers from 14064000 which is powered by medical air only.
  • Manufacturer
    Jolife AB

Manufacturer

Jolife AB
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    MHRA