Events

Alerta De Seguridad O Notificaciones De Seguridad para Bag valve mask (BVM) manual resuscitation system

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
  • Número del evento
    MDA/2018/009
  • Fecha
    2018-03-02
  • Fecha de publicación del evento
    2018-03-02
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/bag-valve-mask-bvm-manual-resuscitation-system-risk-of-damage-to-lungs-by-delivery-of-excessive-pressure
  • 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
    Please see images in the document below which show the incorrect and correct orientation of the directional valves. The green nipples on the valves should not point in the same direction.
    Bag valve mask (BVM) manual resuscitation system MDA/2018/009
  • Causa
    Manufactured by intersurgical – valves may be incorrectly oriented, resulting in overpressure of the bag (mda/2018/009).
  • Acción
    Identify and immediately quarantine affected devices (see Field Safety Notice (FSN) for model and lot numbers). Replace with an alternative device where available. If no alternative is available, check the orientation is correct for all valves on quarantined devices before releasing them from quarantine (see Problem). This can be done without opening the packaging. Do not use if the orientation of the valve is incorrect. Follow the instructions in the manufacturer’s FSN to return affected devices. Return the response form to Intersurgical, even if you don’t have affected devices left in stock.

Device

Bag valve mask (BVM) manual resuscitation system
  • Modelo / Serial
  • Descripción del producto
    Specific lot numbers from the following models are affected. See FSN for lot numbers.Intersurgical Code UDI No. NHSSC Code (England only) 7150000 5030267073238 FDE656 7151000 5030267073245 N/A 7152000 5030267073252 FDE658 7152005 5030267102259 N/A 7152006 5030267105632 N/A 7152007 5030267104901 N/A 7152012 5030267143061 N/A 7153000 5030267073276 FDD4288 7153008 5030267124473 N/A 7154000 5030267073283 FDE660
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Dirección del fabricante
    Intersurgical Tel: 0118 9656 362priority@intersurgical.co.uk
  • Empresa matriz del fabricante (2017)
    Etablissement Cosmeplast
  • Source
    MHRA