Events

Alerta De Seguridad O Notificaciones De Seguridad para Acrobat Swing (AC Swing) arm

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 Ondal.

¿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/2013/020
  • Fecha
    2013-03-27
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-acrobat-swing-ac-swing-arm-risk-of-injury-from-detachment-of-the-swing-arm
  • 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
    Risk of injury from detachment of the swing arm.After approximately seven years of use, the plastic spigot joint of the swing arm can fail through fatigue.Ondal issued a Field Safety Notice (61Kb) in December 2012 to the suppliers that use these swing arms. Users should have been informed of this by their respective equipment supplier.
  • Causa
    (ondal) after approximately 7 years of use, the plastic spigot joint of swing arm can fail through fatigue. (mda/2013/020).
  • Acción
    Identify all Ondal swing arms fitted with a plastic spigot.Contact the supplier of the equipment to arrange for them to replace affected swing arms.Users are advised to move lights and monitors carefully until affected swing arms are replaced.

Device

Acrobat Swing (AC Swing) arm
  • Modelo / Serial
  • Descripción del producto
    Acrobat Swing (AC Swing) arm. Manufactured by Ondal.Supplied by various companies to support operating lights and monitors.Delivered from 1999 to 2008 inclusive.Identifying affected devices:The Ondal AC Swing arm may be curved or straight.Curved arms will usually have a plastic spigot joint, which needs to be changed. Some may have a metal spigot joint, which is not affected.Straight arms usually have a metal spigot joint, which is not affected.  However, all straight arms should be checked to confirm that this is the case.Suppliers may have added their name to the product and issued their own Field Safety Notices (FSN) on this issue. Advice includes removing the plastic cap on top of the spigot joint, held in place by a cross-head screw. If the spigot is plastic, contact the supplier of the equipment to arrange for them to replace the affected swing arm.The affected Ondal AC Swing spring arms are widely used in the UK. Suppliers include (but are not limited to) the following: Trumpf Brandon Draeger Martin Merivaara
  • Manufacturer
    Ondal

Manufacturer

Ondal
  • Dirección del fabricante
    Contact the company that supplied you with the swing arm.Known suppliers are: Trumpf Name: Alasdair Owen Telephone number: 01582 399 201 Brandon Name: Mandy Pearson Telephone number: 0113 272 8844 Draeger Name: Doug Sims Telephone number: 01442 292 868 Martin Name: Dr Ingo Haas Telephone number: 00 49 7463 838 185 Merivaara Name: Esko Hyvarinen Telephone number: 00 358 333 94 6186Note: this is not an exhaustive list of suppliers.
  • Empresa matriz del fabricante (2017)
    Orlando Luxembourg Investments Sarl
  • Source
    MHRA