Events

Notificaciones De Seguridad De Campo acerca de BVM (Bag-Valve-Mask) Manual Resuscitation Systems

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Intersurgical Ltd.

¿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
    Field Safety Notice
  • Fecha
    2017-06-05
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    There is a possibility the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment. the instructions for use provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use. this field safety notice gives additional information relating to this specific problem and the additional actions required. .

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Modelo / Serial
    1. All lot numbers up to and including lot 370253 2. All lot numbers up to and including lot 1170673 3. All lot numbers up to and including lot 31753734 4. All lot numbers up to and including lot 170504
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd