Events

Alerta De Seguridad O Notificaciones De Seguridad para SleepStyle CPAP devices

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 Fisher & Paykel Healthcare.

¿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/2010/076
  • Número del evento
    CON094175
  • Fecha
    2010-09-29
  • Fecha de publicación del evento
    2010-09-29
  • 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/CON094175?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 cessation of therapy due to deterioration of power cord.Fisher & paykel healthcare has received reports of deterioration in the connectors of power cords supplied with their cpap flow generators.A power cord that deteriorates will stop working because of a disconnection in the internal wiring, which may lead to arcing and ultimately could cause a melt or breach of the outer cord sheath (insulation); this may arise near the connector that plugs into the cpap unit.
  • Acción
    Ensure that all users, including patients at home, are aware of the manufacturer’s Field Safety Notice. Identify affected devices. The model number and lot number are located on the bottom of the CPAP device. Remove the water chamber or empty it before viewing the bottom of the device. Contact the manufacturer to arrange for a replacement power cord. In the interim users should continue with their CPAP therapy.

Device

SleepStyle CPAP devices
  • Modelo / Serial
  • Descripción del producto
    SleepStyle CPAP devices. Manufactured by Fisher & Paykel Healthcare. Specific model and lot numbers are affected. This device is used for the treatment of obstructive sleep apnoea and delivers continuous positive airway pressure (CPAP) to assist with a patient’s breathing during sleep. The device is for use by adult patients at home or in a sleep laboratory. The model numbers of affected devices are: HC23XAEK and HC23XMEK HC24XAEK and HC24XMEK HC254AEK and HC254MEK HC60XAEK and HC60XMEK (Where X is a number). The relevant LOT numbers are those up to and including 091122. The image below shows where the model and lot number are located on the device label. CPAPs manufactured with lot numbers higher than 091122 have a different power cord and are not subject to this product replacement.
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare