Events

Retiro De Equipo (Recall) de PEDIATRIC ECG/DEFIB/PACING RADIOTRANSLUCENT PADS

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

¿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
    72752
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-11-17
  • 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
    Philips healthcare has made changes to the design of the connection between multifunction electrodes and their heartstart fr3 and heartstart frx aeds. because of this change conmed's multifunction electrodes listed above will not connect to these aeds. the heartstart frx aed unit requires the pads to be pre-connected and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the heartstart fr3 however does not require pre-connection and the user will not discover the compatibility issue until the aed must be used. in this circumstance the failure to connect may result in a delay of therapy which could result in patient death or serious injury. conmed's padpro and r2 devices still work with other phillips aeds which accept plug style connectors. philips healthcare heartstart fr3 and heartstart frx aed units should only be used with the philips brand electrodes specified in the philips medical equipment manuals. conmed's labeling has been updated accordingly.

Device

PEDIATRIC ECG/DEFIB/PACING RADIOTRANSLUCENT PADS
  • Modelo / Serial
    Model Catalog: 2602H (Lot serial: ALL LOT CODES); Model Catalog: 2603H (Lot serial: ALL LOT CODES); Model Catalog: 2516H-PC (Lot serial: ALL LOT CODES); Model Catalog: 2516H (Lot serial: ALL LOT CODES); Model Catalog: 2001H (Lot serial: ALL LOT CODES); Model Catalog: 2001H-C (Lot serial: ALL LOT CODES); Model Catalog: 2001H-PC (Lot serial: ALL LOT CODES)
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    PEDIATRIC RADIOTRANSLUCENT ELECTRODE AND MINI PEDIATRIC RADIOTRANSLUCENT ELECTRODE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    HC