Events

Alerta De Seguridad O Notificaciones De Seguridad para S74 Elite Sport Scooter with Leoch 20 amp/hour batteries

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 Pride Mobility Products 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/2014/013
  • Número del evento
    CON409261
  • Fecha
    2014-04-28
  • Fecha de publicación del evento
    2014-04-28
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON409261?tabName=allTabs
  • 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
    Risk of the scooter batteries overheating and swelling during the charging cycle.  this may result in a reduced range of travel or a failure of the scooter to drive as expected. pride mobility products ltd has identified that the overheating and swelling is caused by a manufacturing fault with the batteries. pride mobility products ltd issued a field safety notice in february 2014. however, it is not clear whether users have received and acted upon this information.
  • Acción
    Identify all users and staff responsible for users of S74 scooters and ensure that they receive the consumer letter attached to the manufacturer’s FSN. All users should contact their dealer for replacement batteries. Action by: All those involved in the provision, prescription and use of scooters.

Device

S74 Elite Sport Scooter with Leoch 20 amp/hour batteries
  • Modelo / Serial
  • Descripción del producto
    S74 Elite Sport Scooter with Leoch 20 amp/hour batteries Specific serial numbers. The following serial numbers are affected. SG211113017FVO – SG211113148FVO inclusive SG216713002FVO – SG216713169FVO inclusive SG219313286FVO – SG219313335FVO inclusive SG219313114FVO – SG219313211FVO inclusive
  • Manufacturer
    Pride Mobility Products Ltd

Manufacturer

Pride Mobility Products Ltd