Alerta De Seguridad O Notificaciones De Seguridad para SLE 4000/5000 ventilator, Power supply unit (PSU) model FP110-410

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 SLE.

¿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/2013/054R
  • Número del evento
    CON297494
  • Fecha
    2013-07-23
  • Fecha de publicación del evento
    2013-07-23
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • 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
    Potential component failure in the power supply unit (psu). failure of the psu will cause the ventilator to alarm and shut down immediately. the manufacturer issued a technical bulletin to its customers in february 2012, recommending replacing the psu. however, the mhra is uncertain whether corrective actions were carried out.
  • Acción
    Locate all affected ventilators and inspect them to identify affected PSUs. Contact the manufacturer for a replacement PSU as soon as possible if the original PSU has not already been replaced. Inform SLE when the PSU has been changed or if the ventilator is not affected. Have an alternative ventilator on standby until any faulty PSUs are replaced. Check supplies to ensure that any spare PSUs are not affected.

Device

  • Modelo / Serial
  • Descripción del producto
    SLE 4000/5000 ventilator. Power supply unit (PSU) model FP110-410. Specific serial numbers. Affected products can be identified as shown below: Affected product Ventilator model SLE 4000: Serial numbers 42040 and below Ventilator model SLE 5000: Serial numbers 53164 and below Power supply unit model FP110-410: Serial numbers from 163746 to 167558 inclusive Other model FP110-410 PSUs outside the above serial range may be affected if they contain ‘tall’ capacitors. These can be checked by following the recommendations in the manufacturer’s technical bulletin .
  • Manufacturer
    SLE

Manufacturer

SLE