Events

Alerta De Seguridad O Notificaciones De Seguridad para Optima XL stubby handle

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 Timesco of London 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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2007/045
  • Número del evento
    CON2031338
  • Fecha
    2007-06-04
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031338
  • 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
    Poor contact between timesco stubby handles and timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation. timesco believe that there may be a possibility that the electrical contact on the stubby handle may become bent out of position when used with an early design of callisto disposable blade (pre november 2003), which depressed the bulb slightly more than the current timesco callisto single-use design and other timesco reuseable blades. this could have resulted in the bulb failing to be lit if the handle was subsequently used with any current timesco design blade. the stubby handle electrical contact is shown in figure 1 below. timesco sent a letter to inform customers of this issue in february 2007 and, as a precautionary measure, they implemented a redesigned contact mechanism in the stubby handle in january 2007 figure 1. stubby handle electrical contact.
  • Acción
    Identify all stubby handles that are currently in use. Regularly check that the contact spring is adequately elevated to make good contact with the laryngoscope bulb when the bulb is depressed. Check the function of the handles before each use.

Device

Optima XL stubby handle
  • Modelo / Serial
  • Descripción del producto
    Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd. Models: 3000.308.10 and 3000.308.10T. A Timesco stubby handle is a short length laryngoscope handle often used for difficult intubations. Callisto blades are also manufactured by Timesco. Instructions for use are supplied with each stubby handle.
  • Manufacturer
    Timesco of London Ltd

Manufacturer

Timesco of London Ltd
  • Empresa matriz del fabricante (2017)
    Timesco
  • Source
    MHRA