Events

Alerta De Seguridad O Notificaciones De Seguridad para BVM (Bag-Valve-Mask) manual resuscitation systems

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 Intersurgical.

¿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
    2017-06-21
  • Fecha de publicación del evento
    2017-06-21
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/bvm-bag-valve-mask-manual-resuscitation-systems-risk-of-delay-to-emergency-treatment
  • 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
    Manufactured by intersurgical – due to a manufacturing fault, the valve may become stuck during storage, leading to the intended tidal volume not being delivered and a delay to treatment.
  • Acción
    Identify all affected devices – see details below. Search for alternative devices to replace affected products (see appendix), and until alternative devices are available follow the guidelines in the Field Safety Notice. Once you have alternatives, quarantine the affected devices and contact Intersurgical.

Device

BVM (Bag-Valve-Mask) manual resuscitation systems
  • Modelo / Serial
  • Descripción del producto
    The following model (REF number) and LOT numbers are affected:REF number LOT number NHS Supply Chain Code 7150000, 7151000, 7151001, 7152000, 7152007, 7152060, 7153000, 7154000, 7155000, 7156000 All lot numbers up to and including lot 370253 7150000 is FDE656, 7152000 is FDE658, 7153000 is FDD4288 7152003 All lot numbers up to and including lot 1170673 n/a 7150006, 7151006, 7152004, 7152005, 7152006, 7152009, 7152012, 7152014, 7152061, 7153006, 7153008 All lot numbers up to and including lot 31753734 n/a 7150170, 7151170, 7152170, 7152172, 7153170 All lot numbers up to and including lot 170504 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Dirección del fabricante
    Chris Randall IntersurgicalTelephone: 0118 9656 362Fax: 0118 9656 356Email: priority@intersurgical.co.uk
  • Empresa matriz del fabricante (2017)
    Etablissement Cosmeplast
  • Source
    MHRA