Events

Retiro De Equipo (Recall) de QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHYSIO-CONTROL CANADA SALES LTD.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    120764
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    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 the affected lots. 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.

Device

QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE
  • Modelo / Serial
    Model Catalog: 3202674-XXX (Lot serial: 516907); Model Catalog: 3202674-XXX (Lot serial: 519815); Model Catalog: 3202674-XXX (Lot serial: 519816)
  • Descripción del producto
    PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM;Quik-Combo pacing/defibrillation/ECG electordes with EDGE System technology and REDI-PAK preconnect system
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC