Events

Alerta De Seguridad O Notificaciones De Seguridad para Lung ventilators

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 ResMed.

¿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
    2017-09-12
  • Fecha de publicación del evento
    2017-09-12
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/lung-ventilators-astral-100-100sc-and-150-potential-power-loss-due-to-faulty-battery
  • 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
    ResMed’s actions:alternative batteries have been developed. Affected batteries are not being recalled.
    batteries will be replaced within the 2-year maintenance period, prioritised according to need. Customers who are concerned about the clinical need of their patients should contact ResMed directly.
    updating the user and clinical guides to advise on the safe use of Astral ventilators when not on AC power.The internal battery is designed to deliver continuous power when the external power source is disrupted.
    It is not intended to serve as a primary power source.Although both internal and external batteries are potentially affected, using both at the same time reduces the risk of power loss as it is highly unlikely that both sets of batteries will fail at the same time.Manufacturer contactsResMed (UK) Ltd
    Tel: 01235 862 997 Option 3
    Email: astralbatterysupport@resmed.com
  • Causa
    Manufactured by resmed – if operated only by the internal battery and this fails, the patient will not be ventilated.
  • Acción
    Identify affected ventilators. Have systems in place to ensure that: users, including patients and carers, understand the problem detailed in the manufacturer’s Field Safety Notice follow the manufacturer’s advice an external battery is connected if the ventilator is used as a mobile unit an additional external power source and backup source of ventilation is available at all times once available, the warning sticker is put on affected ventilators ventilators and external batteries are returned to a service centre for routine maintenance when prompted Return the Field Safety Notice acknowledgement form to ResMed.

Device

Lung ventilators
  • Modelo / Serial
  • Descripción del producto
    All internal, external and spare batteries are potentially affected by this problem. The RPSII battery is not affected.
  • Manufacturer
    ResMed

Manufacturer

ResMed