Events

Notificaciones De Seguridad De Campo acerca de QUIK-COMBO® pacing/defibrillation/ECG electrodes

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Physio-Control.

¿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
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    The purpose of this letter is to advise you that physio-control’s supplier of quik-combo adult, pacing/defibrillation/ecg electrodes with edge system technology and redi-pak preconnect system is voluntarily recalling specific production lots. the defibrillation electrodes are used in conjunction with certain physio-control lifepak® products. this voluntary recall is being conducted due to a low-level potential for damage to the wire insulation during the manufacturing process of these specific lots. no complaints for this issue have been reported from customers. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician burns. no patient injuries have been reported related to this damaged wire insulation issue. .

Device

QUIK-COMBO® pacing/defibrillation/ECG electrodes

Manufacturer

Physio-Control
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    AMPMDRS