Events

Alerta De Seguridad O Notificaciones De Seguridad para Cook Vacuum Pump for IVF

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 Cook Medical.

¿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
  • Fecha
    2018-05-24
  • Fecha de publicación del evento
    2018-05-24
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/cook-vacuum-pump-for-ivf-risk-of-electric-shock-or-burn-to-operator
  • 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
    The manufacturer identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0.The potential hazardous situations which could arise as a result of this include; failure of the device to operate or electric shock or burn to the user.
  • Causa
    Manufactured by cook medical – risk of electric shock or burn, and failure of the device to operate during ivf procedures because of non-compliant mains wiring.
  • Acción
    Identify the affected devices as stated in device details and, in the manufacturer’s, Field Safety Notice (FSN). Ensure that all users receive the manufacturer’s FSN and that they understand the problem. Ensure a residual current device (RCD), which is marked stating its compliance with BS 7071, is fitted to the mains electricity supply to mitigate the risk of a hazardous situation. RCDs are also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI). If you do not have access to an RCD (or equivalent) do not use the vacuum pump until the mains wiring for the unit has been replaced by the manufacturer. If an adverse event occurs relating to this issue please report this to the MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

Cook Vacuum Pump for IVF
  • Modelo / Serial
  • Descripción del producto
    Product Name Reference Part Number Global Product Number Lot Numbers Cook Vacuum Pump™ K-MAR-5200 G49275 All lots
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical
  • Dirección del fabricante
    Cook Medical Ms. Sinead BurkeTel: +353 (0)61 334440Sinead.burke@CookMedical.com
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    MHRA