Events

Rappel de PEDIATRIC ECG/DEFIB/PACING RADIOTRANSLUCENT PADS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CONMED CANADA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72752
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2014-11-17
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    PEDIATRIC RADIOTRANSLUCENT ELECTRODE AND MINI PEDIATRIC RADIOTRANSLUCENT ELECTRODE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    HC