Events

Alerta De Seguridad O Notificaciones De Seguridad para Bedside model 4170 serial numbers: 1 - 998

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 APC Medical 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/2007/095
  • Número del evento
    CON2033312
  • Fecha
    2007-12-06
  • 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/CON2033312
  • 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
    Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off. following the investigation of a returned bedside model 4170 temporary cardiac pacemaker, the manufacturer has concluded that there is a potential for rapid pacing to occur when shutting off the device. this can only occur if there is a failure of a specific electronic component within the pacemaker box, and the rapid pace switch is left on. apc medical ltd issued an advisory notice on 09 november 2007 to all affected uk centres. the manufacturer has developed a software modification to eliminate the possibility of rapid pace pulses from occurring on shutdown. they have requested that all affected pacemakers are returned to them for appropriate upgrade. the temporary cardiac pacemaker can be used while awaiting upgrade provided the rapid pace switch is off when shutting down the device.
  • Acción
    Check that the rapid pace switch is turned off before shutting down the device. Identify all pacemakers with serial numbers 1 - 998 and return to APC Medical Ltd for a software upgrade. Contact APC Medical Ltd customer service department for information on how to schedule the return of your device(s) for upgrade.

Device

Bedside model 4170 serial numbers: 1 - 998
  • Modelo / Serial
  • Descripción del producto
    External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 - 998. Manufactured by APC Medical Ltd. The APC Bedside model 4170 single chamber external temporary cardiac pacemaker is designed in the USA by Pace Medical Inc., produced in the UK by APC Medical Ltd and supplied to UK hospitals by APC Cardiovascular.
  • Manufacturer
    APC Medical Ltd

Manufacturer

APC Medical Ltd